Suche senden
Hochladen
Regulatory Affairs
•
Als PPT, PDF herunterladen
•
11 gefällt mir
•
12,380 views
S
ShabeenaZaidi
Folgen
Diashow-Anzeige
Melden
Teilen
Diashow-Anzeige
Melden
Teilen
1 von 21
Jetzt herunterladen
Empfohlen
responsibilities, role and scope of DRA Professionals
Drug Regulatory Affairs- 2
Drug Regulatory Affairs- 2
Tanuja Bisht
Drug Regulatory Affairs Introduction
Drug Regulatory Affairs
Drug Regulatory Affairs
Namdeo Shinde
Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Regulatory affairs overview.pptx
Regulatory affairs overview.pptx
kajal pradhan
A Brief Introduction about the Regulatory Affairs / Drug Regulatory Affairs (DRA). Introduction to Drug Regulatory Affairs. Why Drug Regulatory Affairs?. Role of Regulatory Affairs Experts. Types of the company hiring RA professionals. RA professional can get employment. Regulatory Bodies.
DRA (Drug Regulatory Affairs) , RA (Regulatory Affairs)
DRA (Drug Regulatory Affairs) , RA (Regulatory Affairs)
Naman Ruhela
Regulatory affairs
Regulatory affairs
sekhara
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Certificate of pharmaceutical product
Certificate of pharmaceutical product
Atul Bhombe
yashmaru987@gmail.com
NEW DRUG APPLICATION ( NDA)
NEW DRUG APPLICATION ( NDA)
Suvarta Maru
An IND is a submission to the food and drug administration (FDA) requesting permission to initiate a clinical study of a new drug product.
Investigational New drug application [INDA]
Investigational New drug application [INDA]
Sagar Savale
Empfohlen
responsibilities, role and scope of DRA Professionals
Drug Regulatory Affairs- 2
Drug Regulatory Affairs- 2
Tanuja Bisht
Drug Regulatory Affairs Introduction
Drug Regulatory Affairs
Drug Regulatory Affairs
Namdeo Shinde
Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Regulatory affairs overview.pptx
Regulatory affairs overview.pptx
kajal pradhan
A Brief Introduction about the Regulatory Affairs / Drug Regulatory Affairs (DRA). Introduction to Drug Regulatory Affairs. Why Drug Regulatory Affairs?. Role of Regulatory Affairs Experts. Types of the company hiring RA professionals. RA professional can get employment. Regulatory Bodies.
DRA (Drug Regulatory Affairs) , RA (Regulatory Affairs)
DRA (Drug Regulatory Affairs) , RA (Regulatory Affairs)
Naman Ruhela
Regulatory affairs
Regulatory affairs
sekhara
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Certificate of pharmaceutical product
Certificate of pharmaceutical product
Atul Bhombe
yashmaru987@gmail.com
NEW DRUG APPLICATION ( NDA)
NEW DRUG APPLICATION ( NDA)
Suvarta Maru
An IND is a submission to the food and drug administration (FDA) requesting permission to initiate a clinical study of a new drug product.
Investigational New drug application [INDA]
Investigational New drug application [INDA]
Sagar Savale
central drug standard control organisation CDSCO and sate licensing authority of India, organisation and their responsibilities
Pharmaceutical Licecnsing authorites of india
Pharmaceutical Licecnsing authorites of india
Atul Bhombe
Industrial Pharmacy
Regulatory requirement for drug approval
Regulatory requirement for drug approval
Kahnu charan panigrahi
drug regulation in india, licensing requirement and approval procedure
Regulatory requirement and approval procedures for drugs
Regulatory requirement and approval procedures for drugs
Atul Bhombe
OK
Guidance for industry changes to an approved nda or anda
Guidance for industry changes to an approved nda or anda
Gaurav Sharma
REGULATORY AFFAIRS
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
JAYACHANDRA AKUTHOTA
Introduction to CTD and eCTD submissions
CTD and eCTD
CTD and eCTD
Girish Swami
New Drug Approval in India
New Drug Approval in India
New Drug Approval in India
Priyank Srivastava, R.Ph
OVERVIEW OF ICH GUIDELINES
ICH GUIDELINES
ICH GUIDELINES
Naveen Kumar
An Overview of CDSCO Registration. The CDSCO stands for Central Drugs Standard Control Organisation is the NRA or National Regulatory Authority under the Directorate General of Health Services, Government of India, and Ministry of Health and Family Welfare. My presentation based on the CDSCO certification, as well as the complete description about the CDSCO and DCGI.
CDSCO Regulatory Authority.pptx
CDSCO Regulatory Authority.pptx
RAHUL PAL
A brief introductory presentation about National Drug Regulatory Authority of India for Indian Pharmaceuticals and Medical Devices i.e. CDSCO. By Pratibha Chaudhary, pursuing Mpharm DRA from Amity University.
CDSCO - Central Licensing Authority
CDSCO - Central Licensing Authority
PratibhaChaudhary16
Indian regulatory requirements- CDSCO
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
JAYACHANDRA AKUTHOTA
CDSCO, State FDA, DCGI
Drug regulatory authority
Drug regulatory authority
Rahul Gawande
this presentation contains all the requirement procedure for drugs and others
regulatory requirnment and approval procedure for drugs and cosmetics, medica...
regulatory requirnment and approval procedure for drugs and cosmetics, medica...
sandeep bansal
this ppt is about dossier in pharmaceutical industry.
Content and format of dossier filling in india
Content and format of dossier filling in india
sandeep bansal
Medicine and healthcare product regulatory agency
MHRA
MHRA
MD Jahidul Islam
1. Introduction During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies. 2. Drug development team 3. Investigational new drug application (INDA) 4. Format and content of IND 5. Preclinical testing 6. The development process IND application and safety 7. Clinical research 8. New drug application 9. Abbreviated new drug application 10. Changes to an approved NDA or ANDA 11. Difference between NDA and ANDA
Approval and Application Process involved in Investigational New Drug (IND)
Approval and Application Process involved in Investigational New Drug (IND)
Nipun Gupta
Basic information for beginners...
eCTD
eCTD
Chandra Mohan
CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)
CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATION
CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATION
R.C patel institute of pharmacutical education and research, shirpur
Regulatory Requirements For New Drug Approval. This topic is from Industrial Pharmacy-II, B.Pharm Final year VIIth semester. It include rule and regulations related to new drug approval for clinical use.
Regulatory Requirements For New Drug Approval
Regulatory Requirements For New Drug Approval
Shagufta Farooqui
Introduction, Historical overview of regulatory affairs, Regulatory authorities, Role of regulatory affair department, Responsibility
Regulatory affairs
Regulatory affairs
SandhyaPunetha1
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...
Yavuz Silay
Greeting From Virtue Insight, I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India. KEY SPEAKERS:- • V. Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission Ministry of Health and Family Welfare Govt. of India • Arun Bhatt, President, ClinInvent Research • Deepa Arora, Vice President - Pharmacovigilance & Global Head - Drug Safety & Risk Management, Lupin • Bhaswat Chakraborty, Senior Vice President, Cadila • Babita Kirodian, Head of Country Pharmacovigilance, Bristol Myers Squibb • Nipom Deka, Regional Pharmacovigilance Manager, Asia, Africa & Middle East, Abbott • Shashidhar Swamy, Head Pharmacovigilance, Wockhardt • Mohammad Salim, Country Safety Lead, Pfizer • Manish Verma, Director Medical Affairs, Sanofi • Karthik Babu, Affiliate Pharmacovigilance Head, Sanofi • Chirag Trivedi, Director & Head of Clinical Study Unit, Sanofi • Priya Chatterjee, Director - Regulatory Affairs, Merck Serono • Milind Antani, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associate • Anand Harugeri, Patient Safety and Regulatory Affairs Manager, Astrazeneca • Deepti Sanghavi, Assistant Manager - Medical Writing, Tata Consultancy Services • Sandeep Sewlikar, Manager – Clinical Affairs, Johnson and Johnson • Girish Parhate, Head Regulatory Affairs, Bayer Pharmaceuticals • Rajashri Survase Ojha, Founder and MD, Raaj GPRAC • Vandana Jolad, Director, VIaTal Pharma Plus Many More... CONFERENCE BOOKING DETAILS:- • Early Bird Discounted Price - Conference Delegate Pass (INR 6,000 + Tax (14%) per delegate) - Book and Pay before 20th July 2015 avail the early bird discounted price. You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in • Standard Price after Early Bird Discounted Time – 1 or 2 Delegates (INR 7,000 + Tax (14%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in • Group Discounts – 3 or 4 Delegates - (INR 6,500 + Tax (14%) per delegate) • Group Discounts – 5 or more Delegates - (INR 5,000 + Tax (14%) per delegate) • Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to TEL: +91 44 65515695, +91 9940043915 or swetha@virtueinsight.co.in In case you or any of your colleagues might be interested in participating in the same, please let me know and I will be happy to call you and help you with the registration. Thank you for your time and consideration. I look forward to hearing from you Thanks, Swetha
9th pharmacovigilance 2015
9th pharmacovigilance 2015
Wildfrontech
Weitere ähnliche Inhalte
Was ist angesagt?
central drug standard control organisation CDSCO and sate licensing authority of India, organisation and their responsibilities
Pharmaceutical Licecnsing authorites of india
Pharmaceutical Licecnsing authorites of india
Atul Bhombe
Industrial Pharmacy
Regulatory requirement for drug approval
Regulatory requirement for drug approval
Kahnu charan panigrahi
drug regulation in india, licensing requirement and approval procedure
Regulatory requirement and approval procedures for drugs
Regulatory requirement and approval procedures for drugs
Atul Bhombe
OK
Guidance for industry changes to an approved nda or anda
Guidance for industry changes to an approved nda or anda
Gaurav Sharma
REGULATORY AFFAIRS
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
JAYACHANDRA AKUTHOTA
Introduction to CTD and eCTD submissions
CTD and eCTD
CTD and eCTD
Girish Swami
New Drug Approval in India
New Drug Approval in India
New Drug Approval in India
Priyank Srivastava, R.Ph
OVERVIEW OF ICH GUIDELINES
ICH GUIDELINES
ICH GUIDELINES
Naveen Kumar
An Overview of CDSCO Registration. The CDSCO stands for Central Drugs Standard Control Organisation is the NRA or National Regulatory Authority under the Directorate General of Health Services, Government of India, and Ministry of Health and Family Welfare. My presentation based on the CDSCO certification, as well as the complete description about the CDSCO and DCGI.
CDSCO Regulatory Authority.pptx
CDSCO Regulatory Authority.pptx
RAHUL PAL
A brief introductory presentation about National Drug Regulatory Authority of India for Indian Pharmaceuticals and Medical Devices i.e. CDSCO. By Pratibha Chaudhary, pursuing Mpharm DRA from Amity University.
CDSCO - Central Licensing Authority
CDSCO - Central Licensing Authority
PratibhaChaudhary16
Indian regulatory requirements- CDSCO
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
JAYACHANDRA AKUTHOTA
CDSCO, State FDA, DCGI
Drug regulatory authority
Drug regulatory authority
Rahul Gawande
this presentation contains all the requirement procedure for drugs and others
regulatory requirnment and approval procedure for drugs and cosmetics, medica...
regulatory requirnment and approval procedure for drugs and cosmetics, medica...
sandeep bansal
this ppt is about dossier in pharmaceutical industry.
Content and format of dossier filling in india
Content and format of dossier filling in india
sandeep bansal
Medicine and healthcare product regulatory agency
MHRA
MHRA
MD Jahidul Islam
1. Introduction During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies. 2. Drug development team 3. Investigational new drug application (INDA) 4. Format and content of IND 5. Preclinical testing 6. The development process IND application and safety 7. Clinical research 8. New drug application 9. Abbreviated new drug application 10. Changes to an approved NDA or ANDA 11. Difference between NDA and ANDA
Approval and Application Process involved in Investigational New Drug (IND)
Approval and Application Process involved in Investigational New Drug (IND)
Nipun Gupta
Basic information for beginners...
eCTD
eCTD
Chandra Mohan
CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)
CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATION
CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATION
R.C patel institute of pharmacutical education and research, shirpur
Regulatory Requirements For New Drug Approval. This topic is from Industrial Pharmacy-II, B.Pharm Final year VIIth semester. It include rule and regulations related to new drug approval for clinical use.
Regulatory Requirements For New Drug Approval
Regulatory Requirements For New Drug Approval
Shagufta Farooqui
Introduction, Historical overview of regulatory affairs, Regulatory authorities, Role of regulatory affair department, Responsibility
Regulatory affairs
Regulatory affairs
SandhyaPunetha1
Was ist angesagt?
(20)
Pharmaceutical Licecnsing authorites of india
Pharmaceutical Licecnsing authorites of india
Regulatory requirement for drug approval
Regulatory requirement for drug approval
Regulatory requirement and approval procedures for drugs
Regulatory requirement and approval procedures for drugs
Guidance for industry changes to an approved nda or anda
Guidance for industry changes to an approved nda or anda
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
CTD and eCTD
CTD and eCTD
New Drug Approval in India
New Drug Approval in India
ICH GUIDELINES
ICH GUIDELINES
CDSCO Regulatory Authority.pptx
CDSCO Regulatory Authority.pptx
CDSCO - Central Licensing Authority
CDSCO - Central Licensing Authority
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
Indian regulatory requirements- CDSCO ( IP-2 / UNIT 5 )
Drug regulatory authority
Drug regulatory authority
regulatory requirnment and approval procedure for drugs and cosmetics, medica...
regulatory requirnment and approval procedure for drugs and cosmetics, medica...
Content and format of dossier filling in india
Content and format of dossier filling in india
MHRA
MHRA
Approval and Application Process involved in Investigational New Drug (IND)
Approval and Application Process involved in Investigational New Drug (IND)
eCTD
eCTD
CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATION
CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATION
Regulatory Requirements For New Drug Approval
Regulatory Requirements For New Drug Approval
Regulatory affairs
Regulatory affairs
Ähnlich wie Regulatory Affairs
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...
Yavuz Silay
Greeting From Virtue Insight, I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India. KEY SPEAKERS:- • V. Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission Ministry of Health and Family Welfare Govt. of India • Arun Bhatt, President, ClinInvent Research • Deepa Arora, Vice President - Pharmacovigilance & Global Head - Drug Safety & Risk Management, Lupin • Bhaswat Chakraborty, Senior Vice President, Cadila • Babita Kirodian, Head of Country Pharmacovigilance, Bristol Myers Squibb • Nipom Deka, Regional Pharmacovigilance Manager, Asia, Africa & Middle East, Abbott • Shashidhar Swamy, Head Pharmacovigilance, Wockhardt • Mohammad Salim, Country Safety Lead, Pfizer • Manish Verma, Director Medical Affairs, Sanofi • Karthik Babu, Affiliate Pharmacovigilance Head, Sanofi • Chirag Trivedi, Director & Head of Clinical Study Unit, Sanofi • Priya Chatterjee, Director - Regulatory Affairs, Merck Serono • Milind Antani, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associate • Anand Harugeri, Patient Safety and Regulatory Affairs Manager, Astrazeneca • Deepti Sanghavi, Assistant Manager - Medical Writing, Tata Consultancy Services • Sandeep Sewlikar, Manager – Clinical Affairs, Johnson and Johnson • Girish Parhate, Head Regulatory Affairs, Bayer Pharmaceuticals • Rajashri Survase Ojha, Founder and MD, Raaj GPRAC • Vandana Jolad, Director, VIaTal Pharma Plus Many More... CONFERENCE BOOKING DETAILS:- • Early Bird Discounted Price - Conference Delegate Pass (INR 6,000 + Tax (14%) per delegate) - Book and Pay before 20th July 2015 avail the early bird discounted price. You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in • Standard Price after Early Bird Discounted Time – 1 or 2 Delegates (INR 7,000 + Tax (14%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in • Group Discounts – 3 or 4 Delegates - (INR 6,500 + Tax (14%) per delegate) • Group Discounts – 5 or more Delegates - (INR 5,000 + Tax (14%) per delegate) • Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to TEL: +91 44 65515695, +91 9940043915 or swetha@virtueinsight.co.in In case you or any of your colleagues might be interested in participating in the same, please let me know and I will be happy to call you and help you with the registration. Thank you for your time and consideration. I look forward to hearing from you Thanks, Swetha
9th pharmacovigilance 2015
9th pharmacovigilance 2015
Wildfrontech
A Day in the Life of a Medical Director
A Day in the Life of a Medical Director
Pharmaceutical & Medical Professionals
Enhance Patient Safety with a 4-Step Social Media Model
Redefining pharmacovigilance-with-social-media
Redefining pharmacovigilance-with-social-media
Dheeraj Girdhani
Redefining-Pharmacovigilance-with-Social-Media
Redefining-Pharmacovigilance-with-Social-Media
Anitha GS
Here's what bio-pharma organizations need to know when transforming the promotional material review and approval process from a transactional requirement to a competitive advantage.
Accelerating Bio-Pharma's Marketing Transformation
Accelerating Bio-Pharma's Marketing Transformation
Cognizant
New data spotlight value of Train + Test approach to close dangerous regulatory knowledge gaps. Expert presents 3-point plan to enhance compliance education (Slide 49 and 55)
Instilling Quality in Promotional Materials from Start to Finish: Effective C...
Instilling Quality in Promotional Materials from Start to Finish: Effective C...
Center for Communication Compliance
Greetings from Virtue Insight, I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will Be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India. Please find the detailed agenda for the same with this email. FMD:- + 91 9171350244 or deepak@virtueinsight.co.in, deepakrajvirtueinsight@gmail.com
9th pharmacovigilance 2015
9th pharmacovigilance 2015
Deepak Raj (2,000+Connections)
9th pharmacovigilance 2015
9th pharmacovigilance 2015
Deepak Raj (2,000+Connections)
Practice Areas: New Product Planning, Business Development and Licensing, Commercial Strategy and Analytics, and Epidemiology and Forecasting. Our boutique expertise is focused on elucidating patient benefits of bio-pharmaceutical products, medical devices, and businesses. With insightful strategies and solutions aimed at planning and growing our clients’ business, our mission is to continue being the “go-to” firm and preferred partner for our clients in their commercial planning and R&D initiatives. Our chief operating principle is an unsurpassable commitment to quality and our philosophy has been to develop and sustain strong long-term relationships with clients based on an in-depth understanding of client needs, rigorous research, sound methodologies, and keeping ahead of industry developments.
Gore & Company Consulting Capabilities
Gore & Company Consulting Capabilities
Prasanna Gore, PhD
LAW
1. Introduction to regulatory affairs (2).pptx
1. Introduction to regulatory affairs (2).pptx
MdJubair13
biotech bulletin-2015-spring
biotech bulletin-2015-spring
Brian Filippini
Biotech Bulletin 2Q2015
Biotech Bulletin 2Q2015
Regina M Maxwell
VIVID approach to supporting providers treating hard-to-reach consumers...
Vivid Provider Mini Capabilities 2009
Vivid Provider Mini Capabilities 2009
lillianthiemann
To avoid stiff fees, reputation damage and the imposition of corporate integrity agreements (CIAs), pharmaceuticals companies need to monitor their speaker programs carefully for compliance to a suite of regulations. We identify those rules and outline a rigorous process based on relevant key performance indicators (KPIs) that will enable pharmas to head off these potential major hits to their bottom line.
Helping Pharmas Manage Compliance Risks for Speaker Programs
Helping Pharmas Manage Compliance Risks for Speaker Programs
Cognizant
Advice for graduates obtaining their first role in the pharmaceutical and medical industry.
Entry into the pharmaceutical and medical industry
Entry into the pharmaceutical and medical industry
Pharmaceutical & Medical Professionals
Pharmaceutical competitive intelligence
Pharmaceutical competitive intelligence
Pharmaceutical competitive intelligence
feriel abidi
What are the key strategies to win in biosimilars market? What should be your plan for payers, physicians, and launch? What should be the focus for pharmaceutical / biosimilar companies? Key Takeaways - - There is a need for a holistic approach to succeed in this market environment - Many biologics are administered by physicians; therefore, more emphasis will have to be directed at the physicians than was the case with small-molecule generics - Carefully constructed incentive from public and private payers / PBMs could boost biosimilar utilization significantly - Companies need to instill confidence & awareness in patients just like they do with other stakeholders - Launch biosimilars in emerging markets before developed markets to develop strong post-marketing data - Manufacturing biosimilars requires scientific expertise and experience - Success Checklist
What strategies should be employed to win in Biosimilars?
What strategies should be employed to win in Biosimilars?
Santhosh R
Short discussion about Regulatory affairs (RA) by Dipak Bhingardeve
Regulatory affairs
Regulatory affairs
Dipak Bhingardeve
Laying out a regulatory strategy for your product that visualizes the steps taken to bring a new or modified product to market could be one of the smartest decisions you can take as a start-up company. The regulatory strategy describes the approach that will be used to meet the regulatory requirements, as well as known industrial standards...
A Regulatory Strategy for your Medical Device
A Regulatory Strategy for your Medical Device
EMMAIntl
Ähnlich wie Regulatory Affairs
(20)
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...
9th pharmacovigilance 2015
9th pharmacovigilance 2015
A Day in the Life of a Medical Director
A Day in the Life of a Medical Director
Redefining pharmacovigilance-with-social-media
Redefining pharmacovigilance-with-social-media
Redefining-Pharmacovigilance-with-Social-Media
Redefining-Pharmacovigilance-with-Social-Media
Accelerating Bio-Pharma's Marketing Transformation
Accelerating Bio-Pharma's Marketing Transformation
Instilling Quality in Promotional Materials from Start to Finish: Effective C...
Instilling Quality in Promotional Materials from Start to Finish: Effective C...
9th pharmacovigilance 2015
9th pharmacovigilance 2015
9th pharmacovigilance 2015
9th pharmacovigilance 2015
Gore & Company Consulting Capabilities
Gore & Company Consulting Capabilities
1. Introduction to regulatory affairs (2).pptx
1. Introduction to regulatory affairs (2).pptx
biotech bulletin-2015-spring
biotech bulletin-2015-spring
Biotech Bulletin 2Q2015
Biotech Bulletin 2Q2015
Vivid Provider Mini Capabilities 2009
Vivid Provider Mini Capabilities 2009
Helping Pharmas Manage Compliance Risks for Speaker Programs
Helping Pharmas Manage Compliance Risks for Speaker Programs
Entry into the pharmaceutical and medical industry
Entry into the pharmaceutical and medical industry
Pharmaceutical competitive intelligence
Pharmaceutical competitive intelligence
What strategies should be employed to win in Biosimilars?
What strategies should be employed to win in Biosimilars?
Regulatory affairs
Regulatory affairs
A Regulatory Strategy for your Medical Device
A Regulatory Strategy for your Medical Device
Regulatory Affairs
1.
By: Shabeena Zaidi
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
Jetzt herunterladen
![[object Object],[object Object],[object Object],[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)