Overview
This course has been designed to provide an essential overview of the key factors when working with the FDA. It will equip senior managers and project managers with pivotal information to enable them to interact with their teams and ask critical questions to ensure the best outcomes when making applications to the FDA.
The programme will provide an overview of the US FDA’s organisational divisions and examine the drug development regulations. It will provide a valuable guide through the review options and discuss the New Drug Application (NDA) process and how the FDA deals with Generics and Biosimilars.
For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.
CPD Hours: 6
Course Content
- Day 1
- Overview of the US Food and Drug Administration (FDA)
- Examining the Drug Development Regulations in the US
- FDA Meetings
- Evaluation of FDA Review Options
- Reviewing the New Drug Application (NDA) process / Biologics Licensing Application (BLA) Process
- Understand ANDA (Generics) and 351K (Biosimilars) Applications
- Review the Importance of Lifecycle Management in the US
Speakers
Andrew Willis
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, where 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 had 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 has over 30 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.
