Regulatory guidance can help guide the overall development plan and activities in determining the fastest path to market, and typically starts well before clinical trials are initiated. The regulatory strategy could map out the nonclinical and clinical testing, and manufacturing information required for registration using current FDA guidelines. The course will provide details on the regulatory strategy, planning, and writing for a successful IND submission, and the next steps after the submission.
- Regulatory Strategy
- What is a regulatory strategy? Why is a strategy important?
- How to develop a regulatory strategy
- Planning and preparing the IND
- Overview of the IND Process
- FDA Regulations, Guidance and Meetings
- To IND or not- when is an IND required?
- Required IND Content and Format; How to prepare the IND; Submission to FDA
- What to expect after the submission
- Question times, tips, how to handle hiccups – what can go wrong, will go wrong!
Who Should Attend
Professionals in small or large pharmaceutical or biopharmaceutical industries who participate in drug development and who are responsible for studies/sections required for the IND. The course is orientated particularly toward those with relatively limited development experience, but offers benefit to other members or representatives on drug-development project teams and their managers, especially those who would benefit from details on the planning of and how an IND application is put together:
- Regulatory affairs personnel
- Project managers
- Clinical, nonclinical, and manufacturing personnel
Anna Metcalfe has over 25 years of experience in Global Regulatory Affairs, specializing in advancing innovative new products through development to market worldwide. Anna provides strategic advice and leadership in the form of product development plans, and detailed regulatory strategies, to ensure efficient progress from research to First-in-Human, Proof of Concept, and Pivotal Studies. She has coordinated many successful Agency meetings and regulatory submissions from the initial IND, through to market authorization. Anna is a highly respected professional and though retired from Industry, she continues to provide expertise through her own independent consultancy, in providing regulatory guidance and reducing risks in development costs.
|Student Ticket:||$250.00||— On Sale||Until: 20/09/19 11:55 PM|
|Basic Member Ticket:||$650.00||— On Sale||Until: 20/09/19 11:55 PM|
|Group Tickets (5+):||$555.00||— On Sale||Until: 20/09/19 11:55 PM|
|Pro/Pro Plus Member Ticket:||$575.00||— On Sale||Until: 20/09/19 11:55 PM|