We are seeking experienced regulatory affairs professionals with a specialization in pharmaceuticals to volunteer as subject-matter experts (SMEs) to help RAPS develop a new eLearning course on navigating pre-application meetings for drugs. This course aims to guide regulatory professionals in enhancing the efficacy and outcome of their pre-application meeting engagements.
Volunteer SMEs will play a crucial role in course development, offering insights into the intricacies of the drug approval process, advising on content applicability, and contributing to a robust learning experience that reflects current trends and best practices.
The ideal volunteer is someone with:
- Knowledge of the drug development lifecycle and regulatory submission strategies.
- Experience with regulatory authority interactions, especially in pre-application settings.
- Commitment to advancing the skills and knowledge of the regulatory affairs community.