FDA`s Expedited Development and Approval Programs: Taking the Mystery out of Expedited Approvals 2017 is a webinar that covers topics such as:
- Best practices for format, style and organization of the each type of expedited approval pathway
- Assessing the eligibility of a product for an expedited approval pathway: drugs, biologics and medical devices
- Pros and cons of applying for each designation
- Best time in the development timeline to apply for each designation
- Managing public information related to each expedited approval pathway
- What to do when a given designation is rejected: general processes to re-apply and appeal
- Common errors and potential solutions
FDA`s Expedited Development and Approval Programs: Taking the Mystery out of Expedited Approvals 2017 is intended for:
- Senior management executives (CEO, COO, CFO, etc)
- Regulatory affairs professionals
- Clinical trial specialists
- Project Managers
- People investing in drug and biologics products
- Regulatory Compliance Associates and Managers