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TEl: +44(0)2071933485
Email:info@paradigmglobalevents.com
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Clinical Trials Supply Chain Global Congress 2016 Europe
Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape
MONDAY – TUESDAY, 11 - 12 APRIL 2016
HILTON LONDON KENSINGTON HOTEL, LONDON, UKMONDAY – TUESDAY,
11 - 12 APRIL 2016
Hilton London Kensington Hotel,
London UK
• Dr. Carlos Camozzi, Chief Medical Officer, ORPHAZYME, DENMARK
• Dr. David Jefferys, Senior Vice President - Global Regulatory, Public Affairs, EISAI, UK
• Dr. Alexander Natz, Secretary General, EUROPEAN CONFEDERATION OF PHARMACEUTICAL ENTREPRENEURS (EUCOPE), BELGIUM
• Dr. Michael Richter, Quality Manager - Global Clinical Supply, ROCHE, SWITZERLAND
• Virginie Roux, TSOM Leader, Clinical Supplies SCP – Studies & Distribution, SANOFI, FRANCE
• Leyla Hannbeck, Chief Pharmacist, NATIONAL PHARMACY ASSOCIATION
• Dr. Michel Mikhail, Pharmaceutical Industry Expert, Germany
• Dr. Amgad Gamil, Senior Director, Vaccines Global Medical Development and Scientific/Clinical Affairs, PFIZER*
• Dr. Bernd Steffens, Director and Global Head Clinical Trial Supplies Unit, BOEHRINGER INGELHEIM*
• Dr. Laween Al-Atroshi, Chief Research Officer, MID-ESSEX HOSPITAL NHS TRUST
• Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde
• Senior Representative from SANOFI, India
• Pieter J. Klaassen, Director, Previously Operations Manager in the NHS
• Senior Representative from TAKEDA, UK
FEATURING KEY STAKEHOLDER EXPERTS
Clinical Trials Supply Chain Global
Congress 2016 Europe
Navigating the Challenging Waters of the Clinical
Trials Supply Chain Landscape
TEl: +44(0)2071933485
Email:info@paradigmglobalevents.com
Web: www.paradigmglobalevents.com
Clinical Trials Supply Chain Global Congress 2016 Europe
Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape
MONDAY – TUESDAY, 11 - 12 APRIL 2016
HILTON LONDON KENSINGTON HOTEL, LONDON, UK
The clinical trial supplies market is expected to reach USD 1,274.3 million by 2020 from USD 904.3 million in 2015, at a CAGR of 7.1%.
(Reportlinker’s Clinical Trial Supplies Market by Products & Services, Phases & Therapeutic Areas - Global Forecast to 2020 2015).
The driving forces behind this phenomenon is the globalization of clinical trial activities, upwards in R&D investments and government
support, rising incidences of various diseases and growing expansion activities by CROs.
With these in mind, Clinical Trials Supply Chain Global Congress 2016 Europe is being organised to provide a unique platform for busi-
ness knowledge sharing and convergence of top tier government, pharmaceuticals, biopharmaceuticals, as well as regional and local
manufacturers to discuss the driving macroeconomic factors, policies and issues that will steer the clinical trials supply chain industry.
Who Will You Meet
Gain Latest Insights On
Presidents, Heads/Chiefs, Directors, VPs and Managers of:
• Clinical Supply Chain
• Clinical Supply Specialist
• Clinical Operations
• Clinical Coordination
• Clinical Supply Planning
• Clinical Materials
• Clinical Logistics / Distribution
• Clinical Purchasing
• PROCESS EXCELLENCE: How Much Influence Does Clinical Trial Supply Has On the Entire Planning Process?
• FLEXIBLE SCHEDULING: Coordinating a Project Efficiently
• NEW EU CLINICAL TRIAL REGULATION: What You Need to Know?
• STORAGE AND DISTRIBUTION: Maintaining Quality and Product Integrity
• PATIENT-CENTRIC APPROACH: Improving Clinical Trial Supply Chain
• Clinical Packaging / Labelling
• Clinical Manufacturing
• Clinical Technical Specialist
• Comparator Specialist/ Sourcer
• Vendor Management/ Contracting
• Lean Processes
• Sourcing
y Congress 2014 Europe
very, Production and Application
ton Kensington | London, UK
w
Hilton London Kensington
Monoclonal Antibody Congress 2014 Europe
Latest Innovations on Discovery, Production and Application
27-28 October 2014 | Hilton Kensington | London, UK
Dear Colleagues,
Monoclonal Antibodies are also known as targeted therapies
because they work by targeting specific proteins on the surface of
the cells. Mabs agents are currently have been successfully used in
the treatment of cancers, tumors and other serious diseases and is
big on the market.
The market size of Monoclonal antibody agents in 2009-2012 grew
at a CAGR of 13% and is expected to rise by more than 12% in
2013-2017 reaching $141 billion in 2017. This is due to great
market demand, new products being approved and also launching
of Mabs generic drugs.
The global industry of Mabs is currently dominated by European
and American companies, however, sales of Mabs in the rest of the
lonal Antibody Congress 2014 Europe
novations on Discovery, Production and Application
27-28 October 2014 | Hilton Kensington | London, UK
known as targeted therapies
specific proteins on the surface of
ntly have been successfully used in
s and other serious diseases and is
hilton london kensington
179-199 holland park ave,
London w11 4ul, united kingdom
reservations: 020 7603 3355
website: www.hilton.com
TEl: +44(0)2071933485
Email:info@paradigmglobalevents.com
Web: www.paradigmglobalevents.com
Clinical Trials Supply Chain Global Congress 2016 Europe
Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape
MONDAY – TUESDAY, 11 - 12 APRIL 2016
HILTON LONDON KENSINGTON HOTEL, LONDON, UK
Key Industry Expert Speakers
Virginie Roux, TSOM Leader, Clinical Supplies SCP – Studies & Distribution, SANOFI, FRANCE
2001: Human Resource Trainer - French Chamber of Commerce and Industry in Morocco
2004-2007: IMP Logistic Manager at Clinical Supply Chain – Sanofi R&D Montpellier
2007-2010: Supply Chain Trial Manager, Leader in the Internal Medicine Projects at Clinical Supply Chain – Sanofi R&D Montpellier
2010-2013: Distribution Project Manager at Clinical Supplies Scientific Core Platform – Sanofi R&D Montpellier
2013-today: TSOM Leader: manager of a projects managers’ team in charge of the packaging and the distribution of supplies (IMP)
for R&D and GMA studies at Clinical Supplies Scientific Core Platform - Sanofi R&D Montpellier
Leyla Hannbeck, Chief Pharmacist, National Pharmacy Association
Leyla is a pharmacist by profession and an expert in UK and EU medicines and pharmacy policy and practice, patient safety and
medicines adherence, medicines management and commissioning and NHS policies. She currently holds the role of Chief Pharmacists
at the National Pharmacy Association (NPA) leading a team of healthcare professionals and has the overall accountability for the NPA
policy and practice support functions, learning and development for healthcare professionals and business development functions.
Leyla represents the organisation and its members to stakeholders and the media and regularly works with commissioners and
decision-makers in influencing policies related to medicines and healthcare. Leyla is also Medicines Safety Officer on behalf of all
pharmacy organisations with less than 50 branches working very closely with NHS England and Medicines Health regulatory Agency
(MHRA).
Dr. Carlos R. Camozzi, Chief Medical Officer, ORPHAZYME, DENMARK
Dr.Carlos Camozzi is the Chief Medical Officer of Orphazyme (Denmark).He has more than 25 years’ experience in the biopharmaceutical
industry,most recently (10 years) within the orphan drugs development and paediatric therapeutic options,and successful achievements
of products approvals by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Prior to
Orphazyme, Dr. Camozzi held roles of increasing responsibility at American Cyanamid (Lederle), Roche and Mepha Ltd. He was the
Medical Director of Orphan Europe-Recordati and VP-Chief Medical Officer of uniQure BV (ex-AMT) for the development of gene-
therapy (GT) for rare diseases, getting the first ever GT approval (Glybera) in western world.
Dr David Jefferys, Senior Vice President - Global Regulatory, Public Affairs, EISAI, UK
David is currently Senior Vice president in Eisai, responsible for Global Regulatory, Government Relations, Public Affairs and Product
Safety. After qualifying in medicine, he practised as a physician and cardiologist, with additional interests in metabolic medicine and
clinical toxicology. He spent 21 years as a senior regulatory in the UK and Europe. He was executive director of licensing in MCA, CPMP
member, chairman of the MRFG and PER committees. He was CEO and Director of the UK Medical Devices Agency and on the creation
of the MHRA acting joint chief executive. He worked on secondment at the EMEA /EMA on benefit risk methodologies.
Since 2005 he has worked for Eisai, currently he is also chairman of the ABPI regulatory committee and a member of the Innovation
Board. Within Efpia he chairs the Regulatory Committee and sits on the International Regulatory Board.
He also co -chairs the IFPMA regulatory policy, standards and technical committee (RPTS). He is a past chairman of both RAPS and
TOPRA and currently serves as the external relations adviser to the TOPRA Board.
He is a past chairman of the CMR Advisory Board and currently sits as a member of the CIRS Scientific advisory Council.
TEl: +44(0)2071933485
Email:info@paradigmglobalevents.com
Web: www.paradigmglobalevents.com
Clinical Trials Supply Chain Global Congress 2016 Europe
Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape
MONDAY – TUESDAY, 11 - 12 APRIL 2016
HILTON LONDON KENSINGTON HOTEL, LONDON, UK
Key Industry Expert Speakers
Dr. Alexander Natz, Secretary General, EUROPEAN CONFEDERATION OF PHARMACEUTICAL ENTREPRENEURS (EUCOPE), BELGIUM
Since 2009,Alexander Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org) in
Brussels and works as lawyer in his own law firm in Düsseldorf (www.natz-law.com). From 2008 to 2013, he was Head of the Brussels
Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer with Sträter Law Firm in Germany
with a special focus on discount agreements and licensing of pharmaceuticals. Dr. Natz also was working in the field of competition
law with the European Commission and the pharmaceutical industry. As research assistant at Duke University (USA) he has dealt with
international pharmaceutical law. His doctorate was supervised by former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich
Everling.
Dr. Michel Mikhail, Pharmaceutical industry Expert, Germany
Dr. Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience and track record of achievement in R & D and
International Regulatory Affairs in large multinational Research-based pharmaceutical companies as well as in the Generic industry.
Dr Mikhail is a Chartered Expert in Pharmacology -Toxicology, he is a chartered Clinical Expert as well as a chartered Analytical Expert.
Dr Mikhail is an Expert in Biosimilars. He served on the Safety working group and Efficacy working Group of the European Federation
of pharmaceutical Industry associations (EFPIA) also as a Topic leader. He served on the Regulatory Group of the European branch of
the Pharmaceutical Research and Manufacturers of America (PhRMA Europe), on the Board, Executive Committee and the Biosimilars
& Regulatory and Scientific Affairs Group of the European Generic medicines Association (EGA), as well as on different associations
and organisations. He is member of The Organisation for Professionals in Regulatory Affairs (TOPRA). Dr Mikhail is and member of the
Expert Committee of the Federal Institute for Risk Assessment, Berlin, and member of the Expert Committee for Toxicology of the United
States Pharmacopea (USP), Washington DC.
Dr. Michael Richter,
Education: Biochemist (University Halle and University Ulm, Germany)
Job Experiences
Science, Marketing, Microbiology
Since 1999 in Investigational Medical Product department F. Hoffmann La- Roche Basel
Clinical Demand and Supply Leader 2005 – 2015
Head Simulation Clinical Supply Chain 2009-2015
Since May 2015: Quality Manager for IMP Europe, deputy Responsible Person IMP
Pieter Klassen
TEl: +44(0)2071933485
Email:info@paradigmglobalevents.com
Web: www.paradigmglobalevents.com
Clinical Trials Supply Chain Global Congress 2016 Europe
Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape
MONDAY – TUESDAY, 11 - 12 APRIL 2016
HILTON LONDON KENSINGTON HOTEL, LONDON, UK
Key Industry Expert Speakers
Laween Al-Atroshi, Chief Research Officer, Mid-Essex Hospital NHS Trust.
Laween Al-Atroshi, was seconded to Central Government (UK Department of Health) for a year to the Clinical Governance Team. He
is currently the Chief Research Officer for Mid-Essex NHS Trust. The Trust provides a county-wide plastics, head and neck and upper
gastrointestinal (GI) surgical centre to a population of 3.4 million and a world renowned supra regional burns service at the St Andrew’s
Centre, that serves a population of 9.8 million. He is the Good Clinical Practice program lead for North Thames network and also was
Labour Party’s Parliamentary candidate for Surrey Heath.
In his spare time, he is involved in philanthropic activities where he guests on programmes across the media. Recently, he was a
speaker at the Exclusive Digital Marketing Innovation Summit in London on ‘Marketing Hurdles Digital Media Must Overcome’.
Dr Samantha Carmichael, Lead Pharmacist Clinical Trials / R&D, Clinical R & D, NHS GREATER GLASGOW AND CLYDE
Samantha Carmichael has over 20 years experience as a pharmacist, having spent time in many different areas of pharmacy, including
hospital pharmacy and within the private sector working for a large international pharmaceutical company. She is currently the Lead
Pharmacist for Clinical Trials and Research & Development within NHS Greater Glasgow & Clyde where she is also one of the Lead
Sponsor Representatives when they act as a non-commercial sponsor of studies . NHS Greater Glasgow & Clyde is the largest
healthboard in the UK, providing healthcare services to a population of 1.2 million in the West of Scotland. She manages a team of
pharmacists and pharmacy technicians who deliver on studies sponsored by NHS GGC or co-sponsored with the University of Glasgow,
as well as hosting around 400 CTIMPs across all phases and therapeutic areas. She has practised as a clinical pharmacist in the areas
of oncology, critical care and anaesthetics. As well as her Pharmacy degree from the University of Strathclyde, she received an MSc
in Clinical Pharmacology from the University of Glasgow and a PhD in Population Pharmacokinetics, from the University of Edinburgh.
Senior Representative from Sanofi, India - Awaiting Photo and Bio
Senior Representative from Takeda UK - Awaiting Photo and Bio
TEl: +44(0)2071933485
Email:info@paradigmglobalevents.com
Web: www.paradigmglobalevents.com
Clinical Trials Supply Chain Global Congress 2016 Europe
Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape
MONDAY – TUESDAY, 11 - 12 APRIL 2016
HILTON LONDON KENSINGTON HOTEL, LONDON, UK
1st DAY OF CONGRESS | MONDAY, 11 APRIL 2016
08:00 Registration
09:00 Chairperson’s Opening Remarks
MAXIMISING CLINICAL SUPPLIES IN THE PLANNING PROCESS
09:10 Achieving Process Excellence in the End-to-End Clinical Trial Supply Chain
<Presentation>
• Recognising clinical trial supply chain as a key component to the planning process
• What fundamental improvements should be incorporated in the clinical trial supply chain in progressing the growth of pharmaceutical and
biotechnology companies?
Dr. Alexander Natz, Secretary General, EUROPEAN CONFEDERATION OF PHARMACEUTICAL ENTREPRENEURS (EUCOPE), BELGIUM
09:50 What Are Some of the Strategies and Approaches in Optimising the Clinical Trials Supply Chain?
<Panel Discussion>
• Review regulatory considerations pertaining to patient safety and aligning your organisation’s clinical strategies effectively
• What are some of the ways organisations can stay compliant and up to speed with global and regional regulations?
• Identify issues which are delaying your supply chain
• How can you build best practice risk management approach into your clinical trial supply chain?
Panellists:
Dr. Alexander Natz, Secretary General, EUROPEAN CONFEDERATION OF PHARMACEUTICAL ENTREPRENEURS (EUCOPE), BELGIUM
Dr. Laween Al-Atroshi, Chief Research Officer, MID-ESSEX HOSPITAL NHS TRUST
Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde
10:30 Morning Break & Networking
11:10 Costs Explained: How Can Companies Cut Costs in Clinical Trials Supply Chain Whilst Maintaining Safety and Efficacy
of Their Products?
<Presentation>
• What are some of the ways at which companies can reduce costs whilst mitigate risks?
• What are some of the solutions available and how effective are these solutions?
• How can outsourcing of clinical trials supply and logistics services reduce costs ensure that materials reach trial sites in a timely,
efficient manner?
Dr. Bernd Steffens, Director and Global Head Clinical Trial Supplies Unit, BOEHRINGER INGELHEIM*
11:50 End-to-End Approach in Clinical Supply Chain – The Challenge of Blinding
<Presentation>
• Kit separation as reason for unblinding accidents in clinical trials and how to avoid it
• packaging strategies to avoid unblinding accidents
• I(x)R support to avoid unblinding accidents
• challenges for blinding at bulk level
• quality by design instead of quality by control in release process
Dr. Michael Richter, Quality Manager - Global Clinical Supply, ROCHE, SWITZERLAND
12:30 Networking Lunch
TEl: +44(0)2071933485
Email:info@paradigmglobalevents.com
Web: www.paradigmglobalevents.com
Clinical Trials Supply Chain Global Congress 2016 Europe
Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape
MONDAY – TUESDAY, 11 - 12 APRIL 2016
HILTON LONDON KENSINGTON HOTEL, LONDON, UK
13:30	 Clinical trial Regultion and update on its delayed implementation till 2018 instead of 2016.
• EU Clinical Trial Regulation Update
• Background/Effective date/ transition period
• Key provisions/Benefits
• Single Authorisation
• EU Clinical Trial Portal and Database - Critical Path
Dr. Michel Mikhail, Phamaceutical Industry Expert, Germany
14:10	 The EU Clinical Trial Regulation: What You Need to Know
<Presentation>	
• What are the advantages for pharma companies with the new regulation?
• What do companies have to do to prepare for the new regulation?
Dr. David Jefferys, Senior Vice President - Global Regulatory, Public Affairs, EISAI, UK
14:50	 Tea Break & Networking
15:30	 How Has the New European Good Distribution Practice (GDP) Increased the Demand for Clinical Trials Supply Chain Industry?
<Presentation>
• What roles do pharmaceutical companies play in preparing for inspections concerning the new GDP guidelines and what must be done
to collaborate with their supply chain providers?
• How has the requirement of temperature controlled handling and storage for pharmaceuticals change the industry and what must the industry
do to remain competitive?
• How can companies strategise a good risk-based approach for organising modes of transport and transport processes whilst working with third
party logistics provider?
16.10	 Medicines storage, record-keeping, pharmacovigilance, professional indemnity etc?				
<Presentation>
Leyla Hannbeck, Chief Pharmacist, NATIONAL PHARMACY ASSOCIATION
16:50	 Industry forecast and expectations do not match NHS reality
Pieter J. Klaassen, Director, Previously Operations Manager in the NHS
17:30	 Chairperson’s Closing Remark & End of Day 1
17:30 - 18:30 	 Networking Drinks
TEl: +44(0)2071933485
Email:info@paradigmglobalevents.com
Web: www.paradigmglobalevents.com
Clinical Trials Supply Chain Global Congress 2016 Europe
Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape
MONDAY – TUESDAY, 11 - 12 APRIL 2016
HILTON LONDON KENSINGTON HOTEL, LONDON, UK
2nd DAY OF CONGRESS | TUESDAY, 12 APRIL 2016
08:00 Registration
08:45 Chairperson’s Opening Remarks
INVENTORY MANAGEMENT, DISTRIBUTION & FULFILLMENT
09:10 Lean and Mean: Lean Management as a Tool to Improve the Clinical Trial Supply
Clinical Supply Logistics for Investigator-Initiated Studies (giving perspective of an academic sponsor – I would included some aspects of patient
considerations that we give as we have insight to sponsor & site needs/challenges.)
• Understanding the system impact of the lean management implementation clinical supply chain
• How will lean operation affect cost whilst ensuring treatment and supply continuity?
Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde
09:50 Direct To Patient: Delivery of clinical trial materials from an investigator site, pharmacy, or depot directly to a patient’s home
<Presentation>
• Context & Objectives/Advantages
• Process Overview & Regulatory Considerations
• Detailed Procedure
Virginie Roux, TSOM Leader, Clinical Supplies SCP – Studies & Distribution, SANOFI, FRANCE
10:30 Morning Break & Networking
11:10 What Efficient Methods Are Available When Labelling and Packaging Products?
<Presentation>
• How to label time and temperature sensitive products?
• What technologies are available and how will these technologies continue to drive the clinical trials logistics industry?
11:50 Case Study: Ensuring The Safety and Efficacy of Vaccine Supply for Use in Clinical Trials
<Presentation>
• What must sponsors and supply chain managers do to ensure the safe passage of vaccines?
Dr. Amgad Gamil, Senior Director, Vaccines Global Medical Development and Scientific/Clinical Affairs, PFIZER*
12:30 Networking Lunch
INVENTORY MANAGEMENT, DISTRIBUTION & FULFILLMENT
TEl: +44(0)2071933485
Email:info@paradigmglobalevents.com
Web: www.paradigmglobalevents.com
Clinical Trials Supply Chain Global Congress 2016 Europe
Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape
MONDAY – TUESDAY, 11 - 12 APRIL 2016
HILTON LONDON KENSINGTON HOTEL, LONDON, UK
PATIENT CENTRICITY
13:30 The Patient-Centric Approach: Improving the Clinical Trial Supply Chain
<Panel Discussion>
• What does it truly mean to be patient-centric?
• How can supplies influence the patient experience?
• What approaches can stakeholders take to ensure patients’ needs are met?
Panellists:
Dr. Carlos Camozzi, Chief Medical Officer, ORPHAZYME, DENMARK
Dr. Laween Al-Atroshi, Chief Research Officer, MID-ESSEX HOSPITAL NHS TRUST
Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde
14:10 Direct-to-Patient Distribution Model: Driving Efficiencies and Improving the Patients’ Experience
<Presentation>
• How can sponsors ensure that clinical trial materials are delivered to patients’ home on time and within product specifications?
• How to determine that trial materials and specimens are packaged and classified properly according to the country’s regulatory requirements?
Dr. Carlos Camozzi, Chief Medical Officer, ORPHAZYME, DENMARK
14:50 Tea Break & Networking
15:30 Opportunities and Challenges for Clinical Research in Emerging Markets
<Presentation>
• The challenges in keeping up-to-date on the latest clinical trial regulations and what are the strategies to overcome these challenges?
• How can companies cope with the rapid patient enrollment such as China and India?
• How can companies ensure that healthcare professionals are trained to conduct trials in emerging markets?
Senior Representative from SANOFI, India
16:10 What Technologies Are Available Today to Ensure the Safety and Data Accuracy of Clinical Trials?
<Presentation>
• How will technology for clinical trials logistics evolve to cater to multi-location trials?
• How can new technology contribute to the safety and data accuracy of clinical trials?
• How will this change affect emerging markets?
Senior Representative from TAKEDA, UK
16:50 Chairperson’s Closing Remark & End of Conference
PATIENT CENTRICITY
TEl: +44(0)2071933485
Email:info@paradigmglobalevents.com
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Clinical Trials Supply Chain Global Congress 2016 Europe
Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape
MONDAY – TUESDAY, 11 - 12 APRIL 2016
HILTON LONDON KENSINGTON HOTEL, LONDON, UK
11
Biosimilars Global Congress 2014 Europe
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of this booking form, inclusive or exclusive of payment constitutes formal agreement to attend
and acceptance of the terms and conditions stated and are sold on a firm sales basis.
Payment Terms
Paradigm Global Events Ltd requires full payment of the amount to be made at the time of
booking via credit card. We reserve the right to decline any booking for the event. If payment
is not made at the time of the booking an event, then an invoice will be issued and must be
paid in full within 14 days from the date of the booking stated on the invoice and immediately
prior to the event. A credit card guarantee may be requested if the full payment has not been
received in full before the event and payment will be taken before entry to the event. We are
unable to allow a delegate to attend an event or have access to the Document Portal unless
payment has been received in full by us prior to commencement of the event. Paradigm
Global Events reserves the right to charge interest on unpaid invoices.
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The event organized by Paradigm Global Events Ltd, a limited liability company formed under
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  • 1. TEl: +44(0)2071933485 Email:info@paradigmglobalevents.com Web: www.paradigmglobalevents.com Clinical Trials Supply Chain Global Congress 2016 Europe Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape MONDAY – TUESDAY, 11 - 12 APRIL 2016 HILTON LONDON KENSINGTON HOTEL, LONDON, UKMONDAY – TUESDAY, 11 - 12 APRIL 2016 Hilton London Kensington Hotel, London UK • Dr. Carlos Camozzi, Chief Medical Officer, ORPHAZYME, DENMARK • Dr. David Jefferys, Senior Vice President - Global Regulatory, Public Affairs, EISAI, UK • Dr. Alexander Natz, Secretary General, EUROPEAN CONFEDERATION OF PHARMACEUTICAL ENTREPRENEURS (EUCOPE), BELGIUM • Dr. Michael Richter, Quality Manager - Global Clinical Supply, ROCHE, SWITZERLAND • Virginie Roux, TSOM Leader, Clinical Supplies SCP – Studies & Distribution, SANOFI, FRANCE • Leyla Hannbeck, Chief Pharmacist, NATIONAL PHARMACY ASSOCIATION • Dr. Michel Mikhail, Pharmaceutical Industry Expert, Germany • Dr. Amgad Gamil, Senior Director, Vaccines Global Medical Development and Scientific/Clinical Affairs, PFIZER* • Dr. Bernd Steffens, Director and Global Head Clinical Trial Supplies Unit, BOEHRINGER INGELHEIM* • Dr. Laween Al-Atroshi, Chief Research Officer, MID-ESSEX HOSPITAL NHS TRUST • Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde • Senior Representative from SANOFI, India • Pieter J. Klaassen, Director, Previously Operations Manager in the NHS • Senior Representative from TAKEDA, UK FEATURING KEY STAKEHOLDER EXPERTS Clinical Trials Supply Chain Global Congress 2016 Europe Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape
  • 2. TEl: +44(0)2071933485 Email:info@paradigmglobalevents.com Web: www.paradigmglobalevents.com Clinical Trials Supply Chain Global Congress 2016 Europe Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape MONDAY – TUESDAY, 11 - 12 APRIL 2016 HILTON LONDON KENSINGTON HOTEL, LONDON, UK The clinical trial supplies market is expected to reach USD 1,274.3 million by 2020 from USD 904.3 million in 2015, at a CAGR of 7.1%. (Reportlinker’s Clinical Trial Supplies Market by Products & Services, Phases & Therapeutic Areas - Global Forecast to 2020 2015). The driving forces behind this phenomenon is the globalization of clinical trial activities, upwards in R&D investments and government support, rising incidences of various diseases and growing expansion activities by CROs. With these in mind, Clinical Trials Supply Chain Global Congress 2016 Europe is being organised to provide a unique platform for busi- ness knowledge sharing and convergence of top tier government, pharmaceuticals, biopharmaceuticals, as well as regional and local manufacturers to discuss the driving macroeconomic factors, policies and issues that will steer the clinical trials supply chain industry. Who Will You Meet Gain Latest Insights On Presidents, Heads/Chiefs, Directors, VPs and Managers of: • Clinical Supply Chain • Clinical Supply Specialist • Clinical Operations • Clinical Coordination • Clinical Supply Planning • Clinical Materials • Clinical Logistics / Distribution • Clinical Purchasing • PROCESS EXCELLENCE: How Much Influence Does Clinical Trial Supply Has On the Entire Planning Process? • FLEXIBLE SCHEDULING: Coordinating a Project Efficiently • NEW EU CLINICAL TRIAL REGULATION: What You Need to Know? • STORAGE AND DISTRIBUTION: Maintaining Quality and Product Integrity • PATIENT-CENTRIC APPROACH: Improving Clinical Trial Supply Chain • Clinical Packaging / Labelling • Clinical Manufacturing • Clinical Technical Specialist • Comparator Specialist/ Sourcer • Vendor Management/ Contracting • Lean Processes • Sourcing y Congress 2014 Europe very, Production and Application ton Kensington | London, UK w Hilton London Kensington Monoclonal Antibody Congress 2014 Europe Latest Innovations on Discovery, Production and Application 27-28 October 2014 | Hilton Kensington | London, UK Dear Colleagues, Monoclonal Antibodies are also known as targeted therapies because they work by targeting specific proteins on the surface of the cells. Mabs agents are currently have been successfully used in the treatment of cancers, tumors and other serious diseases and is big on the market. The market size of Monoclonal antibody agents in 2009-2012 grew at a CAGR of 13% and is expected to rise by more than 12% in 2013-2017 reaching $141 billion in 2017. This is due to great market demand, new products being approved and also launching of Mabs generic drugs. The global industry of Mabs is currently dominated by European and American companies, however, sales of Mabs in the rest of the lonal Antibody Congress 2014 Europe novations on Discovery, Production and Application 27-28 October 2014 | Hilton Kensington | London, UK known as targeted therapies specific proteins on the surface of ntly have been successfully used in s and other serious diseases and is hilton london kensington 179-199 holland park ave, London w11 4ul, united kingdom reservations: 020 7603 3355 website: www.hilton.com
  • 3. TEl: +44(0)2071933485 Email:info@paradigmglobalevents.com Web: www.paradigmglobalevents.com Clinical Trials Supply Chain Global Congress 2016 Europe Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape MONDAY – TUESDAY, 11 - 12 APRIL 2016 HILTON LONDON KENSINGTON HOTEL, LONDON, UK Key Industry Expert Speakers Virginie Roux, TSOM Leader, Clinical Supplies SCP – Studies & Distribution, SANOFI, FRANCE 2001: Human Resource Trainer - French Chamber of Commerce and Industry in Morocco 2004-2007: IMP Logistic Manager at Clinical Supply Chain – Sanofi R&D Montpellier 2007-2010: Supply Chain Trial Manager, Leader in the Internal Medicine Projects at Clinical Supply Chain – Sanofi R&D Montpellier 2010-2013: Distribution Project Manager at Clinical Supplies Scientific Core Platform – Sanofi R&D Montpellier 2013-today: TSOM Leader: manager of a projects managers’ team in charge of the packaging and the distribution of supplies (IMP) for R&D and GMA studies at Clinical Supplies Scientific Core Platform - Sanofi R&D Montpellier Leyla Hannbeck, Chief Pharmacist, National Pharmacy Association Leyla is a pharmacist by profession and an expert in UK and EU medicines and pharmacy policy and practice, patient safety and medicines adherence, medicines management and commissioning and NHS policies. She currently holds the role of Chief Pharmacists at the National Pharmacy Association (NPA) leading a team of healthcare professionals and has the overall accountability for the NPA policy and practice support functions, learning and development for healthcare professionals and business development functions. Leyla represents the organisation and its members to stakeholders and the media and regularly works with commissioners and decision-makers in influencing policies related to medicines and healthcare. Leyla is also Medicines Safety Officer on behalf of all pharmacy organisations with less than 50 branches working very closely with NHS England and Medicines Health regulatory Agency (MHRA). Dr. Carlos R. Camozzi, Chief Medical Officer, ORPHAZYME, DENMARK Dr.Carlos Camozzi is the Chief Medical Officer of Orphazyme (Denmark).He has more than 25 years’ experience in the biopharmaceutical industry,most recently (10 years) within the orphan drugs development and paediatric therapeutic options,and successful achievements of products approvals by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Prior to Orphazyme, Dr. Camozzi held roles of increasing responsibility at American Cyanamid (Lederle), Roche and Mepha Ltd. He was the Medical Director of Orphan Europe-Recordati and VP-Chief Medical Officer of uniQure BV (ex-AMT) for the development of gene- therapy (GT) for rare diseases, getting the first ever GT approval (Glybera) in western world. Dr David Jefferys, Senior Vice President - Global Regulatory, Public Affairs, EISAI, UK David is currently Senior Vice president in Eisai, responsible for Global Regulatory, Government Relations, Public Affairs and Product Safety. After qualifying in medicine, he practised as a physician and cardiologist, with additional interests in metabolic medicine and clinical toxicology. He spent 21 years as a senior regulatory in the UK and Europe. He was executive director of licensing in MCA, CPMP member, chairman of the MRFG and PER committees. He was CEO and Director of the UK Medical Devices Agency and on the creation of the MHRA acting joint chief executive. He worked on secondment at the EMEA /EMA on benefit risk methodologies. Since 2005 he has worked for Eisai, currently he is also chairman of the ABPI regulatory committee and a member of the Innovation Board. Within Efpia he chairs the Regulatory Committee and sits on the International Regulatory Board. He also co -chairs the IFPMA regulatory policy, standards and technical committee (RPTS). He is a past chairman of both RAPS and TOPRA and currently serves as the external relations adviser to the TOPRA Board. He is a past chairman of the CMR Advisory Board and currently sits as a member of the CIRS Scientific advisory Council.
  • 4. TEl: +44(0)2071933485 Email:info@paradigmglobalevents.com Web: www.paradigmglobalevents.com Clinical Trials Supply Chain Global Congress 2016 Europe Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape MONDAY – TUESDAY, 11 - 12 APRIL 2016 HILTON LONDON KENSINGTON HOTEL, LONDON, UK Key Industry Expert Speakers Dr. Alexander Natz, Secretary General, EUROPEAN CONFEDERATION OF PHARMACEUTICAL ENTREPRENEURS (EUCOPE), BELGIUM Since 2009,Alexander Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org) in Brussels and works as lawyer in his own law firm in Düsseldorf (www.natz-law.com). From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer with Sträter Law Firm in Germany with a special focus on discount agreements and licensing of pharmaceuticals. Dr. Natz also was working in the field of competition law with the European Commission and the pharmaceutical industry. As research assistant at Duke University (USA) he has dealt with international pharmaceutical law. His doctorate was supervised by former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling. Dr. Michel Mikhail, Pharmaceutical industry Expert, Germany Dr. Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical companies as well as in the Generic industry. Dr Mikhail is a Chartered Expert in Pharmacology -Toxicology, he is a chartered Clinical Expert as well as a chartered Analytical Expert. Dr Mikhail is an Expert in Biosimilars. He served on the Safety working group and Efficacy working Group of the European Federation of pharmaceutical Industry associations (EFPIA) also as a Topic leader. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America (PhRMA Europe), on the Board, Executive Committee and the Biosimilars & Regulatory and Scientific Affairs Group of the European Generic medicines Association (EGA), as well as on different associations and organisations. He is member of The Organisation for Professionals in Regulatory Affairs (TOPRA). Dr Mikhail is and member of the Expert Committee of the Federal Institute for Risk Assessment, Berlin, and member of the Expert Committee for Toxicology of the United States Pharmacopea (USP), Washington DC. Dr. Michael Richter, Education: Biochemist (University Halle and University Ulm, Germany) Job Experiences Science, Marketing, Microbiology Since 1999 in Investigational Medical Product department F. Hoffmann La- Roche Basel Clinical Demand and Supply Leader 2005 – 2015 Head Simulation Clinical Supply Chain 2009-2015 Since May 2015: Quality Manager for IMP Europe, deputy Responsible Person IMP Pieter Klassen
  • 5. TEl: +44(0)2071933485 Email:info@paradigmglobalevents.com Web: www.paradigmglobalevents.com Clinical Trials Supply Chain Global Congress 2016 Europe Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape MONDAY – TUESDAY, 11 - 12 APRIL 2016 HILTON LONDON KENSINGTON HOTEL, LONDON, UK Key Industry Expert Speakers Laween Al-Atroshi, Chief Research Officer, Mid-Essex Hospital NHS Trust. Laween Al-Atroshi, was seconded to Central Government (UK Department of Health) for a year to the Clinical Governance Team. He is currently the Chief Research Officer for Mid-Essex NHS Trust. The Trust provides a county-wide plastics, head and neck and upper gastrointestinal (GI) surgical centre to a population of 3.4 million and a world renowned supra regional burns service at the St Andrew’s Centre, that serves a population of 9.8 million. He is the Good Clinical Practice program lead for North Thames network and also was Labour Party’s Parliamentary candidate for Surrey Heath. In his spare time, he is involved in philanthropic activities where he guests on programmes across the media. Recently, he was a speaker at the Exclusive Digital Marketing Innovation Summit in London on ‘Marketing Hurdles Digital Media Must Overcome’. Dr Samantha Carmichael, Lead Pharmacist Clinical Trials / R&D, Clinical R & D, NHS GREATER GLASGOW AND CLYDE Samantha Carmichael has over 20 years experience as a pharmacist, having spent time in many different areas of pharmacy, including hospital pharmacy and within the private sector working for a large international pharmaceutical company. She is currently the Lead Pharmacist for Clinical Trials and Research & Development within NHS Greater Glasgow & Clyde where she is also one of the Lead Sponsor Representatives when they act as a non-commercial sponsor of studies . NHS Greater Glasgow & Clyde is the largest healthboard in the UK, providing healthcare services to a population of 1.2 million in the West of Scotland. She manages a team of pharmacists and pharmacy technicians who deliver on studies sponsored by NHS GGC or co-sponsored with the University of Glasgow, as well as hosting around 400 CTIMPs across all phases and therapeutic areas. She has practised as a clinical pharmacist in the areas of oncology, critical care and anaesthetics. As well as her Pharmacy degree from the University of Strathclyde, she received an MSc in Clinical Pharmacology from the University of Glasgow and a PhD in Population Pharmacokinetics, from the University of Edinburgh. Senior Representative from Sanofi, India - Awaiting Photo and Bio Senior Representative from Takeda UK - Awaiting Photo and Bio
  • 6. TEl: +44(0)2071933485 Email:info@paradigmglobalevents.com Web: www.paradigmglobalevents.com Clinical Trials Supply Chain Global Congress 2016 Europe Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape MONDAY – TUESDAY, 11 - 12 APRIL 2016 HILTON LONDON KENSINGTON HOTEL, LONDON, UK 1st DAY OF CONGRESS | MONDAY, 11 APRIL 2016 08:00 Registration 09:00 Chairperson’s Opening Remarks MAXIMISING CLINICAL SUPPLIES IN THE PLANNING PROCESS 09:10 Achieving Process Excellence in the End-to-End Clinical Trial Supply Chain <Presentation> • Recognising clinical trial supply chain as a key component to the planning process • What fundamental improvements should be incorporated in the clinical trial supply chain in progressing the growth of pharmaceutical and biotechnology companies? Dr. Alexander Natz, Secretary General, EUROPEAN CONFEDERATION OF PHARMACEUTICAL ENTREPRENEURS (EUCOPE), BELGIUM 09:50 What Are Some of the Strategies and Approaches in Optimising the Clinical Trials Supply Chain? <Panel Discussion> • Review regulatory considerations pertaining to patient safety and aligning your organisation’s clinical strategies effectively • What are some of the ways organisations can stay compliant and up to speed with global and regional regulations? • Identify issues which are delaying your supply chain • How can you build best practice risk management approach into your clinical trial supply chain? Panellists: Dr. Alexander Natz, Secretary General, EUROPEAN CONFEDERATION OF PHARMACEUTICAL ENTREPRENEURS (EUCOPE), BELGIUM Dr. Laween Al-Atroshi, Chief Research Officer, MID-ESSEX HOSPITAL NHS TRUST Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde 10:30 Morning Break & Networking 11:10 Costs Explained: How Can Companies Cut Costs in Clinical Trials Supply Chain Whilst Maintaining Safety and Efficacy of Their Products? <Presentation> • What are some of the ways at which companies can reduce costs whilst mitigate risks? • What are some of the solutions available and how effective are these solutions? • How can outsourcing of clinical trials supply and logistics services reduce costs ensure that materials reach trial sites in a timely, efficient manner? Dr. Bernd Steffens, Director and Global Head Clinical Trial Supplies Unit, BOEHRINGER INGELHEIM* 11:50 End-to-End Approach in Clinical Supply Chain – The Challenge of Blinding <Presentation> • Kit separation as reason for unblinding accidents in clinical trials and how to avoid it • packaging strategies to avoid unblinding accidents • I(x)R support to avoid unblinding accidents • challenges for blinding at bulk level • quality by design instead of quality by control in release process Dr. Michael Richter, Quality Manager - Global Clinical Supply, ROCHE, SWITZERLAND 12:30 Networking Lunch
  • 7. TEl: +44(0)2071933485 Email:info@paradigmglobalevents.com Web: www.paradigmglobalevents.com Clinical Trials Supply Chain Global Congress 2016 Europe Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape MONDAY – TUESDAY, 11 - 12 APRIL 2016 HILTON LONDON KENSINGTON HOTEL, LONDON, UK 13:30 Clinical trial Regultion and update on its delayed implementation till 2018 instead of 2016. • EU Clinical Trial Regulation Update • Background/Effective date/ transition period • Key provisions/Benefits • Single Authorisation • EU Clinical Trial Portal and Database - Critical Path Dr. Michel Mikhail, Phamaceutical Industry Expert, Germany 14:10 The EU Clinical Trial Regulation: What You Need to Know <Presentation> • What are the advantages for pharma companies with the new regulation? • What do companies have to do to prepare for the new regulation? Dr. David Jefferys, Senior Vice President - Global Regulatory, Public Affairs, EISAI, UK 14:50 Tea Break & Networking 15:30 How Has the New European Good Distribution Practice (GDP) Increased the Demand for Clinical Trials Supply Chain Industry? <Presentation> • What roles do pharmaceutical companies play in preparing for inspections concerning the new GDP guidelines and what must be done to collaborate with their supply chain providers? • How has the requirement of temperature controlled handling and storage for pharmaceuticals change the industry and what must the industry do to remain competitive? • How can companies strategise a good risk-based approach for organising modes of transport and transport processes whilst working with third party logistics provider? 16.10 Medicines storage, record-keeping, pharmacovigilance, professional indemnity etc? <Presentation> Leyla Hannbeck, Chief Pharmacist, NATIONAL PHARMACY ASSOCIATION 16:50 Industry forecast and expectations do not match NHS reality Pieter J. Klaassen, Director, Previously Operations Manager in the NHS 17:30 Chairperson’s Closing Remark & End of Day 1 17:30 - 18:30 Networking Drinks
  • 8. TEl: +44(0)2071933485 Email:info@paradigmglobalevents.com Web: www.paradigmglobalevents.com Clinical Trials Supply Chain Global Congress 2016 Europe Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape MONDAY – TUESDAY, 11 - 12 APRIL 2016 HILTON LONDON KENSINGTON HOTEL, LONDON, UK 2nd DAY OF CONGRESS | TUESDAY, 12 APRIL 2016 08:00 Registration 08:45 Chairperson’s Opening Remarks INVENTORY MANAGEMENT, DISTRIBUTION & FULFILLMENT 09:10 Lean and Mean: Lean Management as a Tool to Improve the Clinical Trial Supply Clinical Supply Logistics for Investigator-Initiated Studies (giving perspective of an academic sponsor – I would included some aspects of patient considerations that we give as we have insight to sponsor & site needs/challenges.) • Understanding the system impact of the lean management implementation clinical supply chain • How will lean operation affect cost whilst ensuring treatment and supply continuity? Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde 09:50 Direct To Patient: Delivery of clinical trial materials from an investigator site, pharmacy, or depot directly to a patient’s home <Presentation> • Context & Objectives/Advantages • Process Overview & Regulatory Considerations • Detailed Procedure Virginie Roux, TSOM Leader, Clinical Supplies SCP – Studies & Distribution, SANOFI, FRANCE 10:30 Morning Break & Networking 11:10 What Efficient Methods Are Available When Labelling and Packaging Products? <Presentation> • How to label time and temperature sensitive products? • What technologies are available and how will these technologies continue to drive the clinical trials logistics industry? 11:50 Case Study: Ensuring The Safety and Efficacy of Vaccine Supply for Use in Clinical Trials <Presentation> • What must sponsors and supply chain managers do to ensure the safe passage of vaccines? Dr. Amgad Gamil, Senior Director, Vaccines Global Medical Development and Scientific/Clinical Affairs, PFIZER* 12:30 Networking Lunch INVENTORY MANAGEMENT, DISTRIBUTION & FULFILLMENT
  • 9. TEl: +44(0)2071933485 Email:info@paradigmglobalevents.com Web: www.paradigmglobalevents.com Clinical Trials Supply Chain Global Congress 2016 Europe Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape MONDAY – TUESDAY, 11 - 12 APRIL 2016 HILTON LONDON KENSINGTON HOTEL, LONDON, UK PATIENT CENTRICITY 13:30 The Patient-Centric Approach: Improving the Clinical Trial Supply Chain <Panel Discussion> • What does it truly mean to be patient-centric? • How can supplies influence the patient experience? • What approaches can stakeholders take to ensure patients’ needs are met? Panellists: Dr. Carlos Camozzi, Chief Medical Officer, ORPHAZYME, DENMARK Dr. Laween Al-Atroshi, Chief Research Officer, MID-ESSEX HOSPITAL NHS TRUST Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde 14:10 Direct-to-Patient Distribution Model: Driving Efficiencies and Improving the Patients’ Experience <Presentation> • How can sponsors ensure that clinical trial materials are delivered to patients’ home on time and within product specifications? • How to determine that trial materials and specimens are packaged and classified properly according to the country’s regulatory requirements? Dr. Carlos Camozzi, Chief Medical Officer, ORPHAZYME, DENMARK 14:50 Tea Break & Networking 15:30 Opportunities and Challenges for Clinical Research in Emerging Markets <Presentation> • The challenges in keeping up-to-date on the latest clinical trial regulations and what are the strategies to overcome these challenges? • How can companies cope with the rapid patient enrollment such as China and India? • How can companies ensure that healthcare professionals are trained to conduct trials in emerging markets? Senior Representative from SANOFI, India 16:10 What Technologies Are Available Today to Ensure the Safety and Data Accuracy of Clinical Trials? <Presentation> • How will technology for clinical trials logistics evolve to cater to multi-location trials? • How can new technology contribute to the safety and data accuracy of clinical trials? • How will this change affect emerging markets? Senior Representative from TAKEDA, UK 16:50 Chairperson’s Closing Remark & End of Conference PATIENT CENTRICITY
  • 10. TEl: +44(0)2071933485 Email:info@paradigmglobalevents.com Web: www.paradigmglobalevents.com Clinical Trials Supply Chain Global Congress 2016 Europe Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape MONDAY – TUESDAY, 11 - 12 APRIL 2016 HILTON LONDON KENSINGTON HOTEL, LONDON, UK 11 Biosimilars Global Congress 2014 Europe Registration form 17th - 19th September 2014 | London, UK Standard Price Per Delegate: Conference Only £1299 + VAT Discount Code: _______________ Distribution of promotional literature : £700 +Vat Distribution of your company’s promotional literature to all the attendees Date of Booking: Title: Forename: Surname: Company: Job Title: Department / Division: Main Switchboard Number: Address: Post /Zip Code: Direct Line: Direct Fax: Mobile: Direct Email Address: Signature: I confirm that I have read and agree to the terms and conditions of the booking. 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Receipt of this booking form, inclusive or exclusive of payment constitutes formal agreement to attend and acceptance of the terms and conditions stated and are sold on a firm sales basis. Payment Terms Paradigm Global Events Ltd requires full payment of the amount to be made at the time of booking via credit card. We reserve the right to decline any booking for the event. If payment is not made at the time of the booking an event, then an invoice will be issued and must be paid in full within 14 days from the date of the booking stated on the invoice and immediately prior to the event. A credit card guarantee may be requested if the full payment has not been received in full before the event and payment will be taken before entry to the event. We are unable to allow a delegate to attend an event or have access to the Document Portal unless payment has been received in full by us prior to commencement of the event. Paradigm Global Events reserves the right to charge interest on unpaid invoices. Cancellation The event organized by Paradigm Global Events Ltd, a limited liability company formed under English company law and registered in the UK. Cancellations received in writing more than 45 days before the conference date, will be eligible for 50% of the due less a £75 administration fee. If you are unable to send substitution then Cancellations must be made in writing. Cancellations made less than 45 days before the event date will not be entitled to a refund. Substitutions / Name Changes If you are unable to attend you may nominate, in writing, another delegate to take your place any time prior to the start of the events. Two or more delegates may not share a place at an event. Please make separate bookings for each delegate. Alterations Paradigm Global Events Ltd reserves the right to make alterations to the event / executive briefing content, timing, speakers or program and venues beyond our control. The event may be postponed or cancelled due to unforeseen events beyond the control of Paradigm Global Events Ltd. We have no liability for any loss of trade or profit occurring to the customer as a result of a charge or cancellation. Paradigm Global Events Ltd will not accept liability for any transport disruption or individual transport delays and in such circumstances the normal cancellation restrictions apply. Data Protection The information that we collect and store relating to you is primarily used to enable us to provide our services to you, to respond to your inquiries about our offerings, and to offer you other products, programs or services that we believe may be of interest to you. We sometimes use such information to communicate with you. If you choose to submit content for event publication or event program, we may publish your name and other information you have provided to us. If you are a previous or existing customer, we may contact you with information about products and services similar to those, which were the subject of a previous sale to you. Furthermore, we may use your data, or permit selected third parties to use your data, so that you can be provided with information about unrelated products and services which we consider may be of interest to you. We or they may contact you about these products and services by any methods that you consented at the time your information was collected. As set out above, we are committed to safeguarding your personal information. Whenever you provide such information, we are legally obliged to use your information in line with all laws concerning the protection of personal information, including the Data Protection Act 1998 (these laws are referred to collectively in this Privacy Policy as the “data protection laws” Fee: The event fee includes lunch, refreshments and conference documents provided on the day. This fee does not include travel, hotel accommodation, transfers or insurance. Payment of Invoice Our aim is to establish and maintain a long-term business relationship with all our clients and customers, however failure to pay in accordance with clause causes us significant problems and expense in chasing late payers. For late payers we will take action to enforce full payment of the invoice, and without prejudice any other rights, to terminate the contract with you in respect of any future supplies and to compensation for debt recovery cost under “The Late Payment of Commercial Debts (Interest)” Act 1998 as amended and supplemented by “The Late Payment of Commercial Debts Regulations 2002”. In jurisdictions where this may not apply you accept that equivalent interest (8% above UK base rate) and debt recovery fees (minimum £40) will be payable to offset our costs in this matter. We may set and vary credit limits from time to time and may not accept any further orders if such credit limits are exceeded. If you have a problem with any product or service please contact us immediately and we will try and resolve the issue. You should however pay the invoice in full by the due date to prevent further action! Delegate Details Terms and Conditions of Booking Formation and Incorporation: There is a 50% liability on all bookings once made, whether by fax, email or by post. Receipt of this booking form, inclusive or exclusive of payment constitutes formal agreement to attend and acceptance of the terms and conditions stated and are sold on a firm sales basis. Payment Terms Paradigm Global Events Ltd requires full payment of the amount to be made at the time of booking via credit card. We reserve the right to decline any booking for the event. If payment is not made at the time of the booking an event, then an invoice will be issued and must be paid in full within 14 days from the date of the booking stated on the invoice and immediately prior to the event. A credit card guarantee may be requested if the full payment has not been received in full before the event and payment will be taken before entry to the event. We are unable to allow a delegate to attend an event or have access to the Document Portal unless payment has been received in full by us prior to commencement of the event. Paradigm Global Events reserves the right to charge interest on unpaid invoices. Cancellation The event organized by Paradigm Global Events Ltd, a limited liability company formed under English company law and registered in the UK. Cancellations received in writing more than 45 days before the conference date, will be eligible for 50% of the due less a £75 administration fee. If you are unable to send substitution then Cancellations must be made in writing. Cancellations made less than 45 days before the event date will not be entitled to a refund. Substitutions / Name Changes If you are unable to attend you may nominate, in writing, another delegate to take your place any time prior to the start of the events. Two or more delegates may not share a place at an event. Please make separate bookings for each delegate. Alterations Paradigm Global Events Ltd reserves the right to make alterations to the event / executive briefing content, timing, speakers or program and venues beyond our control. The event may be postponed or cancelled due to unforeseen events beyond the control of Paradigm Global Events Ltd. We have no liability for any loss of trade or profit occurring to the customer as a result of a charge or cancellation. Paradigm Global Events Ltd will not accept liability for any transport disruption or individual transport delays and in such circumstances the normal cancellation restrictions apply. Data Protection The information that we collect and store relating to you is primarily used to enable us to provide our services to you, to respond to your inquiries about our offerings, and to offer you other products, programs or services that we believe may be of interest to you. We sometimes use such information to communicate with you. If you choose to submit content for event publication or event program, we may publish your name and other information you have provided to us. If you are a previous or existing customer, we may contact you with information about products and services similar to those, which were the subject of a previous sale to you. Furthermore, we may use your data, or permit selected third parties to use your data, so that you can be provided with information about unrelated products and services which we consider may be of interest to you. We or they may contact you about these products and services by any methods that you consented at the time your information was collected. As set out above, we are committed to safeguarding your personal information. Whenever you provide such information, we are legally obliged to use your information in line with all laws concerning the protection of personal information, including the Data Protection Act 1998 (these laws are referred to collectively in this Privacy Policy as the “data protection laws” Fee: The event fee includes lunch, refreshments and conference documents provided on the day. This fee does not include travel, hotel accommodation, transfers or insurance. Payment of Invoice Our aim is to establish and maintain a long-term business relationship with all our clients and customers, however failure to pay in accordance with clause causes us significant problems and expense in chasing late payers. For late payers we will take action to enforce full payment of the invoice, and without prejudice any other rights, to terminate the contract with you in respect of any future supplies and to compensation for debt recovery cost under “The Late Payment of Commercial Debts (Interest)” Act 1998 as amended and supplemented by “The Late Payment of Commercial Debts Regulations 2002”. In jurisdictions where this may not apply you accept that equivalent interest (8% above UK base rate) and debt recovery fees (minimum £40) will be payable to offset our costs in this matter. We may set and vary credit limits from time to time and may not accept any further orders if such credit limits are exceeded. If you have a problem with any product or service please contact us immediately and we will try and resolve the issue. You should however pay the invoice in full by the due date to prevent further action! Delegate Details Card Billing Address: Direct Tel: Direct Mobile: Email address: Card Holder’s Signature: By Electronic Bank Transfer: Please transfer the full funds to Paradigm Global Events Ltd bank account. Methods of Payment: All payment must be made in Sterling.