FDA`s Expedited Development and Approval Programs: Taking the Mystery out of Expedited Approvals 2017

Topics

• 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

Who should Attend

• 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