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.
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: Understanding FDA meetings
- An overview of the different types of FDA meetings
- Create a best practice guide for meeting preparation and attendance
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
- US regional requirements
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
- FDA homepage
Final discussion and review of day
An independent consultant with 32 years of experience with regulatory affairs and pharmaceutical development. Experience at multiple levels within pharmaceutical companies and most recently as Vice President for Regulatory Affairs, gaining significant experience in co-ordinating, planning and running global development projects.
His experience is wide ranging, allowing fast, effective development of medicinal products, through early stages, through registration and continued Life Cycle Management.
Since acting as an independent consultant his roles have included:
- Interim Strategic advice to major pharmaceutical company for roll-out and compliance strategies for Russia / CIS, MENA, ASEAN, LATAM, South Africa and Switzerland, including ensuring appropriate staff development and strategies which ensure protection of intellectual property whilst maintain patient focus.
- Orphan drug registrations of vaccine products and synthetic molecules
- NCE approved in US and Europe for urology product (Simultaneous NDA and EU Centralised submission)
- Support for NBE during clinical phases and CMC support for a Biosimilar, Biosimilar / Biologic CMC reviewer for major pharma. Biosimilar experience includes working on first EU biosimilar onwards.
- Oversight of Regulatory strategy for ATMP (Cancer vaccine) and CMC lead for Stem Cell treatment
- Training to major pharmaceutical companies for Chemistry and Pharmacy section of the dossier and Life Cycle Management. Additional lead training / presentations on Life Cycle Management for TOPRA.
Furthermore, his responsibilities have provided senior management oversight and direction in the following key areas: -
- Strategic management of ATMP products for Biotech start-up company
- Strategic Biosimilar team, developing a global biotech and biosimilar strategy for key biosimilar products.
- Global Quality Leadership Team, providing oversight and direction for global quality processes.
- Innovation Team, providing oversight and direction for the innovation.
Additional experiences reflect raising funds for new start-up companies and associated due diligence activities. Also he has substantial awareness of management of P & L performance, growth initiatives related to service expansion, geographical expansion and innovative business development approaches.