For anyone interested in developing for and registering products in USA, this course will give all the required information about how to set-up your product development and successfully achieve registration with FDA.
To whom it may concern
• Regulatory Affairs Manager, Officer and Specialist
• Quality Manager
• Development Pharmacist
• Pharmacovigilance Manager
• Project Manager
working for pharmaceutical company and CROs whit specific interest in FDA regulation.
Basic regulatory knowledge would be preferred
FDA basics and Overview of Regulatory Affairs in US
Systematic introduction to FDA and principle regulatory activities for drug development and registration
a) FDA in general; recent political changes and their consequences
b) Outline of US regulation of drugs and biologicals; RA timelines actions, acronyms
c) Comparison of US vs. EU regulatory mechanisms
d) Current Hot Topics
FDA regulatory affairs during Drug Development
Overview of all important regulatory topics during product development phases
a) US Agent requirements
b) Formal meetings with FDA
Practical Case: pre-IND meetings with FDA
When and how to approach the agency
a) Practical case: preparing meetings with FDA
FDA application types and dossier requirements
Introduction to all important application types and respective dossiers:
b) New Drug Applications: NDA, Art. 505(b)(2), BLA
c) US generic products – the ANDA pathway
eSubmission: FDA eCTD requirements
Overview of current and future US eCTD requirements, including analysis of differences between USA and Europe
a) FDA eCTD requirements and comparison FDA & EU
b) How to comply with specifications for M1, M5, SPL, STF, etc.
c) Dossier and document requirements
Orphan Drug Designation (ODD)
a) US ODD requirements
b) Comparison EU vs. USA
Pediatric Product Development
Introduction to all important application types and respective dossiers
a) US legislation
b) BPCA and PREA: requirements, incentives, procedures and timelines
c) Comparison EU vs. US
Practical Case: Preparation of an IND
… based on an existing European IMPD. “It’s easy, right?”
a) Differences EU vs. US system
b) Practical case: preparing an IND from EU IMPD
Expedited pathways – Go Faster!
Comprehensive overview of alternative pathways that speed up registration
a) Go faster! Breakthrough Therapy, Fast Track, Accelerated Approval, and Priority Review
b) Overview of FDA incentives: Vouchers, Waivers and Designations
Parallel development in EU and US
… from the perspective of EU biotech companies
a) Strategic considerations before initiating EU-US parallel development
b) Practical case: EU company developing in US
Short introduction into the maintenance of FDA authorized products:
a) Post Approval Changes, Annual Reports, and Comparability Protocols
Type of Training
Theoretical explanation of US requirements, practical tips and tricks and use case explanation and examples on how to develop and register your product with FDA and Q&A sessions.
At the end of the training, you will be able to:
Understand the US regulatory landscape and requirements. Be able to develop and register your products in US, by understanding the Regulatory environment
Lidia Canovas, Director of Regulatory Affairs, Asphalion S.L.
Lidia has a Pharmacy and MBA degree. She has fifteen years overall experience in pharmaceutical industry, ten years as Regulatory Affairs Director and four years as Vice-Director for Research and Development. She has been working at Asphalion for ten years as General Manager and Director of Regulatory Affairs. As director of Regulatory Affairs at Asphalion, Lidia is
responsible for the overall quality of the Regulatory and Scientific services that Asphalion provides to a large number of international and national clients.
Bruce Thompson, Principal at Reguliance
Bruce is an independent consultant with over 20 years’ experience in the pharmaceutical and biotech industries, possessing practical skills in the details of product development planning, regulatory strategy, and project management. He is Principal of Reguliance, which he founded in 2002. He has previous experience in the pharmaceutical industry as Managing Director, Director of Regulatory Affairs and Acting Director for US Regulatory Affairs for several companies during 10 years. He is member of the American Society of Gene & Cell Therapy (ASGCT), the Licensing Executives Society (LES) and the Regulatory Affairs Professionals Society – RAPS (certified 1994).