Two-Day UK Seminar: The FDA Drug Approval Process (London, United Kingdom – September 19th-20th, 2019) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “The
FDA Drug Approval Process” conference has been added to ResearchAndMarkets.com’s
offering.

A comprehensive overview of FDA procedures, requirements for marketing
authorisations and recent developments affecting the drug approval
process in the US.

This course is designed to help you gain a better understanding
of the US drug approval process. You will gain a practical
insight into FDA requirements for submission of NDAs, ANDAs and
505(b)(2). It will also cover the organisation and structure of the FDA
and review processes, as well as discuss recent changes.

The course will emphasise areas of interest to innovative manufacturers,
but will also deal with issues relating to generic and over-the-counter
drugs.

Benefits of attending:

• Gain an overview of FDA drug development regulatory requirements
• Comply with FDA requirements for NDAs, ANDAs and 505(b)(2)
• Discuss recent changes and developments
• Improve your communication and interactions with the FDA

Who Should Attend:

This programme will be especially beneficial to those responsible for
preparing US registration documents (INDs, NDAs, Biologics License
Applications, etc), regulatory affairs personnel, lawyers and others
responsible for advising companies on strategies for developing new
drugs for the US market.

Agenda:

Programme Day one

An overview of the US FDA Drug development regulatory
requirements for FDA

• Overview of INDs
• Data requirements for drug substance and drug product
• Pre-clinical testing and clinical testing
• The different phases of development

Drug development regulatory requirements for FDA (continued)

Overview of the IND application and the data requirements

• IND structure
• Submission procedure
• IND review
• FDA actions

Maintenance of INDs

• Structure and content of STED
• Technical file vs design dossier

Identifying recent changes

• Examining accelerated review and breakthrough status
• Paediatric legislation
• Financial disclosure
• Clinical trial transparency
• Exclusivity and patent declaration

Workshop: Optimising your meetings

• An overview of the different types of FDA meetings
• Create a best practice guide for FDA meetings

Programme Day two

Identifying the NDA types and categories

• What is a full NDA?
• 505(b)(2) applications
• CTD requirements
• FDA approach to CTD format
• Review approach
• Biologics and biosimilars (BLA)

Review of ANDA/NDA

Understanding ANDA classification

• Examining paragraph I-IV
• Overview of GDUFA

US change control – amendments

• NDA/ANDA amendments
• SUPAC/BACPAC guidance
• Annual reports/CBE and PAS applications
• NDA annual report requirements

Obtaining information from the FDA

• Access to Federal Register
• FOIA
• FDA homepage

Final discussion and review of day

Speakers:

Andrew Willis

Consultant

Independent

Andrew Willis is an independent consultant providing expert advice and
training on global regulatory solutions and pharmaceutical development.
Previously, he worked for Catalent Pharma Solutions as VP Regulatory
Affairs & Consulting Services. Catalent is the world’s leading contract
manufacturer and distributor of pharmaceuticals, and he was head of a
team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which
he furthered his understanding of pharmaceutical development, working as
a research chemist with Parke Davis. He has 10 years’ manufacturing and
analytical experience prior to entering regulatory affairs as a Senior
Executive Officer with responsibility for submission of European MAAs
and project management of development programs.

He currently has a total of 28 years’ pharmaceutical experience with
extensive knowledge in the development and manufacture of sterile, solid
oral, inhalation, topical and biotech pharmaceutical products. These
experiences have allowed knowledge of many Biotech products requirements
with experiences of growth hormones and multiple cancer treatments,
including development and clinical registration of the first genetically
modified live bacterium for such treatment.

He has extensive experience of major European and US regulatory
projects, in the clinical and marketing authorisation stages, and has
significant experience in coordinating and managing meetings with
European and US Health Authorities.

Specific experience includes the project management of a large MAA
requiring full clinical data, followed by Mutual Recognition of the
application in all of the European Concerned Member States. The project
recorded successful outcomes in all major markets (26 countries) and was
viewed as highly successful by the client, meeting very stringent
project timings.

For more information about this conference visit https://www.researchandmarkets.com/r/7g6cqr

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
[email protected]
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Related
Topics: Drug
Discovery