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3rd Congress Efficient eCTD Submissions 2011
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3rd Congress
Submissions 2011
EU- Regulators - New EU Variations Regulation – Lifecycle Management – PIM
31st January – 2nd February 2011 | Meliá Hotel, Berlin
Leading companies and institutions will • Meet key EU regulators and gain insights into the adoption and requirements of eCTD to get
present case studies and solutions on efficient your submission accepted as quickly as possible
eCTd Submissions:
• Hear best practices on the successful handling of eCTD lifecycle management and document
Bayer Schering Pharma AG, Germany strategies to avoid costly pitfalls
Merck Serono, Germany • Profit from first experiences of the New EU Variation Regulation concerning implementation
deadlines and consequences
Danish Medicines Agency, Denmark
• Learn how to adopt eCTD in small and medium-sized companies to make sure that you will
College ter Beoordeling van
choose the right strategy for your company
Geneesmiddelen, CBG-MEB, Netherlands
• Hear best solutions on handling Product Information Management (PIM) and gain insights into the
Agence Française de Sécurité Sanitaire des
impact on eCTD submissions to ensure the best product migration process
Produits de Santé, Afssaps, France
División Tecnologías Información, Agencia
Benefit from contributors such as:
Española de Medicamentos y Productos Dr. Adam Aparicio, Head of Global Rob De Haan, Deputy Director MEB,
Sanitarios, AEMPS, Spain Regulatory Operations, College ter Beoordeling van
Merck Serono, Germany Geneesmiddelen, Netherlands
Gebro Pharma GmbH, Austria
PARI Pharma GmbH, Germany Elke Schydlo, Technical Services, Global Miguel BLEy, Head of European Affairs,
Regulatory Affairs Agence Française de Sécurité Sanitaire
German Medicines Manufacturers Manager, Submission Services Hannover, des Produits de Santé (Afssaps), France
Association, BAH, Germany Abbott Products GmbH, Germany
Federal Institut for Drugs and Medical
Devices, BfArM, Germany INTERACTIVE WORkSHOP DAy | Wednesday, 2nd February 2011
Abbott Products GmbH, Germany
A Implementation of eCTD in sme (small and medium-sized companies)
B eCTD Technical Validation Criteria - How to get eCTDs through technical validation
Schering Plough Netherlands B.V.,
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To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.ectd-kongress.de/MM
2. Efficient eCTD Submissions 2011
3rd Congress
31st January – 2nd February 2011 | Meliá Hotel, Berlin
Dear colleagues, Who will you meet?
Submission documents have traditionally been handed in to agencies on paper, meanwhile electronic systems • Regulatory Affairs
• Global Regulatory Operations
are used for building and managing these documents. Nowadays electronic-only submission (eCTD) is, how-
• Documentation Management
ever, becoming ever more mandatory. For example, since 2009 electronic-only submission has been mandato-
• Submission Management
ry at the EMA in England. eCTD could constitute a huge advantage for pharma industries because the submis- • Regulatory Lifecycle Management
sion time can be substantially reduced, allowing for a quicker release of products onto the market. However, • IT Regulatory Support
the implementation and handling of eCTD are problematic due to different standards at each European
agency. The implementation of eCTD in the company also means a change of the workflow and a high
demand on archiving and managing the electronic documents (lifecycle management). Furthermore the
Sponsorship
New EU Variations Regulation (since January 2010) denotes modification when it comes to reporting varia-
tions to the agency. We have a variety of packages
available to suit your requirements.
For all Sponsorship and Exhibition
Discuss the challenges of efficient eCTD submissions at our opportunities call Ralph Grundmann:
+49 (0) 30 20 91 32 75 or email
ralph.grundmann@iqpc.de.
3rd Congress
Efficient eCTD Submissions
EU Regulators – New EU Variations Regulation – Lifecycle Management – PIM Sponsor
31.01.-02.02.2011 | Meliá Hotel, Berlin
Find out how to:
• get eCTDs through technical validation at agencies COI GmbH
• prepare PIM submissions Erlanger Strasse 62
91074 Herzogenaurach, Germany
• implement eCTD in small and medium-sized companies
Tel.: +49 (0)9132 7383 3417
Fax: +49 (0)9132 7383 4959
Join our expert panel, save your place and book today! Email: andrej.sosnin@coi.de
www.coi.de
We look forward to welcoming you to our 3rd congress Efficient eCTD Submissions in Berlin!
Kind Regards,
For further information
please visit our website
www.ectd-kongress.de/MM or con-
Team Discounts tact Hannah Schädler or
Monica Wick Mark Reichmann via
We are offering attractive Team
Project Manager email eq@iqpc.de.
Discounts, please contact us!
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of specialisation that requires Regulatory Affairs Managers to be a pharmacist, lawyer, quality manager and project manager in
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looking for, it is easy to get lost in the sheer abundance of information and lose valuable time. In contrast, the Guide to Drug
Regulatory Affairs eases you through the necessary procedures, comments on EU and EMEA documents and helps you draw up
your application. ECV • Editio Cantor Verlag GmbH www.ecv.de
Since 72 years, pharmind® has been the periodical to be read by decision-makers and multipliers of the pharma scene. Taking into
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wPharmaVOICE magazine addresses the challenges and trends impacting the life-sciences industry. PharmaVOICE's subscribers
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To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.ectd-kongress.de/MM
3. Efficient eCTD Submissions 2011
3rd Congress
CONGRESS DAy ONE | Monday, 31st January 2011
09:30 Registration with coffee and tea
PIM & eCTD/ digital signatures
09:55 Chairman’s welcome & opening address
15:00 The PIM Project - Exchange of well structured product
New EU Variations Regulation information
• Why Product Information Management (PIM)?
10:00 Regulators view: Consequences of the New Variation • Structure and elements of the PIM-Project
Regulation for the eCTD • Impact on the procedures of regulators and industry
• EU Module 1.4 specification • Status Update and next steps
• Switch from 1.3 to 1.4 during life-cycle Dr. Andreas Franken, Abteilungsleiter Klinische Forschung/
• Worksharing and grouping, annual reporting elektronische Datenübermittlung,
Dr. Klaus Menges, Division Strategy and Planning-Unit BAH
Scientific Quality Assurance and Process Organisation,
Federal Institut for Drugs and Medical Devices, BfArM 15:45 PIM Submissions
• Exchanging data in PIM
10:45 Industry View: 1 year New Variations Regulation • The PIM process / communication within PIM
• Experiences from MRP and DCP • The lifecycle of PIM / DES
• Q&A Document for eCTD Variations - open questions • PIM implemetation in eCTD
• Impact of "Grouping" and "Annual reporting" on internal Markus Pfahlert, Global Regulatory Operations,
business processes" Merck Serono
Dr. Hannes Perschinka, Regulatory Support,
Gebro Pharma GmbH 16:30 Refreshment break & networking
11:30 Refreshment break & networking 17:00 Digital signatures in eSubmissions in Europe
• Why digital signatures? The use of electronic submission
eCTD in a special environment gateways
• The SAFE standard
12:00 Case Study: Managing MAH and Manufacturer Name • The use of ‘flattened’ digital signatures
Change Submissions in the case of a Company Take-Over • Pilot of digital signatures
• Name Change Project Introduction • Acceptance of digital signatures in the EU
• Tools used for Submission Planning and Tracking Hans van Leeuwen, Program Manager,
• From high level planning to approval offirst submissions Schering Plough Netherlands B.V.
• Reporting tools
• Logistic of Submissions in Europe 17:45 Closing remarks of the chairman and end of day one
• Submission Formats used
• Impact of New Variations Guideline
Elke Schydlo, Technical Services, Global Regulatory Affairs
Manager, Submission Services Hannover,
Abbott Products GmbH The Meliá Berlin invites you to an evening
reception. This is an excellent opportunity
12:45 Challenges faced by small and medium-sized companies for you to meet the other attendees and
• Does it make sense to implement eCTD in my company? make new business contacts.
• How do I get started?
• Two case studies
• Dos and Don'ts
Oliver Denk, PhD, Director, Regulatory Affairs Pharma,
PARI Pharma GmbH For further Information
13:30 Networking Luncheon
please visit our website www.ectd-kongress.de/MM
or contact Hannah Schädler or Mark Reichmann on
+49 (0)30 2091 32 74 or email eq@iqpc.de.
What’s in your download center?
The purpose of the download center is to provide you with relevant content to enhance your knowledge of current trends and industry news.
All content is 100% complimentary, easy to download, and current.
Featuring live podcast interviews, available to stream on your computer or portable device, up-to-date news from local and
international sources, industry whitepapers, and other relevant content – the download centre is your online portal for expanding your knowl-
edge and adding value to your business.
We encourage your feedback and participation. For all comments or enquiries please contact Mark Reichmann or Hannah Schädler on
+49 (0)30 20 91 32 74 or eq@iqpc.de.
Get free white papers, articles and much more!
www.ectd-kongress.de/MM
To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.ectd-kongress.de/MM
4. Efficient eCTD Submissions 2011
3rd Congress
CONGRESS DAy TWO | Tuesday, 1st February 2011
08:30 Registration with coffee and tea 13:20 Practical experience in handling eCTD submissions in
Spanish Medicine Agency
08:55 Chairman’s welcome & opening address • eCTD and NeeS submission: Pros and Cons
Dr. Adam Aparicio, Head of Global Regulatory Operations, Regulator
• Impact of the eCTD on regulatory processes
Merck Serono, Germany
• Common problems handling eCTDs in Spanish Medicine
Implementation and requirements of eCTD by EU Agency
Regulators José Manuel Simarro, División Tecnologías Información,
Agencia Española de Medicamentos y Productos
09:00 Electronic Marketing Authorisation Applications in Sanitarios, AEMPS
Europe Today
• e-Readiness : Regulators and Industry Lifecycle Management – document strategies
Regulator • EU Harmonisation: Guidance and Validation of submissions
• The French experience
14:00 One year of eCTDs in Switzerland - a project review
Miguel Bley, Head of European Affairs,
• How to build Swiss Module 1 in eCTD
Agence Française de Sécurité Sanitaire des Produits de
Santé (Afssaps) • Ensuring successful validation of your submission
• Article 13 in eCTD - referring to existing approvals abroad
09:40 e-submissions at the MEB and the EU portal • Dos and don'ts for Swiss eCTDs
• Current status of e-submissions at the MEB Jörg Schnitzler, Associate Director Regulatory Operations,
• Validation: Improving quality of your submission Regulatory Affairs Europe,
Regulator • CESP: The EU portal dream or reality Astellas Pharma Europe R&D
Rob De Haan, Deputy Director MEB,
College ter Beoordeling van Geneesmiddelen,
14:45 Refreshment break & networking
Netherlands
10:20 Refreshment break & networking 15:15 eCTD Lifecyle management: Milestones and Hurdles
in a DCP
10:50 Experiences with e-only eSubmissions in Germany • Initial Submission and Approval
• Conditions to move to e-only • Lifecycle of the application (Variations, PSURs, FUMs, etc)
• Technical validation: improvement or burden • eCTD and Worksharing
Regulator • Quality of the dossiers
• Feedback from Authorities
• Recommendations for the future
Dr. Christian Dinter, Global Submission Manager,
Dr. Klaus Menges, Division Strategy and Planning-Unit
Scientific Quality Assurance and Process Organisation, Bayer Schering Pharma AG, Germany
Federal Institut for Drugs and Medical Devices, BfArM
16:00 Strategies for documents and lifecycle management
11:30 Experience with e-only submissions in Denmark • Document preparation
• Requirements for applicants • Granularity options - high vs. low
• Experience from validation of e-submissions • Hyperlinking strategy options
Regulator • Quality of dossiers received • Publishing and dossier lifecycle / re-usage
• Working in the Danish Agency’s fully digitalised environment
Dr. Adam Aparicio, Head of Global Regulatory Operations,
Per Helboe, Senior Director of Division,
Danish Medicines Agency Merck Serono, Germany
12:10 Networking Luncheon 16:45 Closing remarks of the chairman and end of congress
day two
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To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.ectd-kongress.de/MM
5. Efficient eCTD Submissions 2011
3rd Congress
INTERACTIVE WORkSHOPDAy | Wednesday, 2nd February 2011
Workshop A
Implementation of eCTD in sme (small and medium-sized companies)
09:30 – 13:00
As eCTD submissions are becoming the norm rather than an exception small and medium-sized companies are now trying
to match their capabilities to what are now industries requirements. The implementation of eCTD format will require a
huge effort therefore it is important to identify priorities in this process.
The participants of the workshop will learn:
• How to reach a decision whether to choose an in-house solution or an outsourcing solution.
• What criteria need to be looked at when choosing the right software tool for eCTD publishing?
• What is the best approach to implement eCTD in your company?
• Which departments need to be involved in the process?
The workshop will be held in a very interactive manner.
Oliver Denk, PhD, Director, Regulatory Affairs Pharma, PARI Pharma GmbH
Workshop B
eCTD Technical Validation Criteria - How to get eCTDs through technical validation at agencies
09:30 – 13:00
The EU eCTD Validation Criteria (v2.1) were published in April 2009. Many European agencies have already started to perform
technical validation of incoming eCTDs and to reject eCTDs not complying with the validation criteria. Different tools for
checking the validation criteria are made available to the public by agencies and vendors (EURS Validator, eValidator, eCTD
Checker). As the interpretation of validation criteria is different between the tools, one eCTD may lead to different validation
results than another.
This workshop will cover
• Introduction to publicly available validation tools (EURS Validator, eValidator, eCTD Checker)
• Interpretation of validation results from different tools
• How should an eCTD be structured to pass all (publicly available) validation tools?
• Outlook on update of EU eCTD Validation Criteria: TIGes has announced that it will issue updated EU validation criteria by
the end of 2010
Dr. Hannes Perschinka, Regulatory Support, Gebro Pharma GmbH
Workshop C
Successfully managing eCTD lifecycles
14:00 – 17:30
To handle the eCTD lifecycle successfully means to be aware of some common pitfalls. Therefore this workshop will provide
you with solutions to solving problems which arise during lifecycle management.
The following topics will be covered:
• Defining level of granularity
• Hypertext link/bookmarking
• Changes during lifecycle
• Grouping and worksharing
• Switch from paper to eCTD during lifecycle
For further Information visit our website: www.ectd-kongress.de/MM
Workshop D
PIM & eCTD
14:00 – 17:30
The content of product information texts for medicinal products is part of any marketing authorisation. SPC, package leaflets
and labeling contain important information for both patients and for professionals such as doctors and pharmacists. The
marketing authorisation holder is responsible for the creation as well as for the maintenance of these informative texts.
While for a national approval only a few pages of text are necessary, the scope of work expands as soon as the product is
marketed in multiple countries with different languages and in addition in different strengths and / or formulations.
A structured electronic generation and submission of these texts, starting with the centralized procedure and maybe later
also for other drug application procedures, is needed as even today the basic regulatory processes are increasingly
converted to paperless communication. The workshop will vividly demonstrate the preparation and handling of product
information in accordance with the requirements of the EMA for PIM. For this the structure of XML documents with the
basic idea of multiple use of information and their advantages in the document maintenance are presented and explained.
This includes an introduction to the free tool for this purpose, the EMA (Light Authoring Tool, LAT).
Dr. Andreas Franken, Clinical Research / eSubmission, German Medicines Manufacturers Association, BAH
To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.ectd-kongress.de/MM