Call for experts for Drug Pre-Application Meetings for Pharmaceuticals eLearning course development

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.