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.
Benefits of Attending
- Learn the critical factors involved when embarking on product development for the US market
- Understand how to communicate effectively about US activities throughout the organisation
- Know the structure of the FDA and how it works
- Understand how to comply with the regulations and requirements
- Discover the best review process for your application
- Learn the requirements and processes for biologics and advanced therapies
- Review the key differences between the EU and FDA applications for Generics (ANDA) and Biosimilars (315k)
- Get the opportunity to understand the complexities and discuss best approaches with an expert in this area
Certifications
- CPD: 6 hours for your records
- Certificate of completion
Agenda
Overview of the US Food and Drug Administration (FDA)
- Brief history of the FDA and Regulations and how we got to where we are today
- Review the FDA’s organisation by division
Examining the Drug Development Regulations in the US
- Clinical trials and Investigational New Drug (INDs)
- Discover who is involved in development and the types of INDs
- Basic understanding of the IND content and timings
- FDA Meetings
- Review the various FDA meetings in accordance with PDUFA VII (Prescription Drug User Fee Amendments)
Evaluation of FDA Review Options
- Understanding the following FDA review options:
- Fast track/Priority review/Accelerated review/Breakthrough status
- Understand the importance of Cell and Gene Therapy in FDA and Regenerative Medicine Advanced Therapies (RMAT) Process/Interact
Reviewing the New Drug Application (NDA) process/Biologics Licensing Application (BLA) Process
- Defining full NDAs/BLA
- Examining the NDA categories
- Explaining abbreviated NDAs and 505 (b) (2)
Understand ANDA (Generics) and 351K (Biosimilars) Applications
- Review of key differences to EU
- Overview of regulatory positions
- US strategies for development
Review the Importance of Lifecycle Management in the US
- Annual reports
- Change being Effective
- Prior Approval Supplements
- Comparison to EU variation regulation
Speakers
Mr Andrew Willis,
Consultant ,
IndependentAndrew 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.
Who Should Attend
- Pharmaceutical and Biopharmaceutical Starts-ups
- Pharmaceutical Executives
- Senior Management
- Business Development Managers
- Regulatory Strategists
- Project Managers
- All those who wish to broaden their knowledge on working with the FDA
