For professionals in the life sciences sector, the RAC (Regulatory Affairs Certification) program serves as a valuable educational tool that enhances both knowledge and career prospects. Achieving an RAC credential is beneficial across a range of industries, including regulatory agencies, government bodies, industry consultancies, healthcare facilities, research, and educational institutions worldwide.
One of the key advantages of obtaining the RAC is the confidence it instills—not just in yourself, but also in those you work with. Adding the RAC to your credentials signals expertise and assures others that you have a thorough understanding of regulations relevant to your field.
The course is designed to provide a comprehensive overview of healthcare product regulations, compliance standards, and offers a global perspective on regulatory affairs. To aid in preparation, online practice exams are available.
Certification from a recognized regulatory body not only boosts your confidence in providing regulatory guidance but also reassures colleagues and clients that you have a deep understanding of regulations specific to your product category, as well as other regulatory frameworks.
Passing an exam created by your peers in the regulatory field validates your expertise in core regulatory components, demonstrating your proficiency within your specialized area.
This advanced course in Regulatory Affairs covers both theoretical and practical aspects, such as:
- Fundamentals of Regulatory Affairs
- Key guidelines like ICH, DMF, ASMF, CTD, eCTD, and an in-depth look at the CTD structure (Modules 1-5)
- Software demonstrations, including eCTD and eValidator (Lorenz DocuBridge), compliant with 21 CFR
- Drug product development and essential documentation for filings
- Preparation and submission of CTD, eCTD, DMF, and applications like IND, NDA, ANDA, BLA
- Insights into regulatory practices for blood products, traditional herbal medicines, cosmetics, food, and dietary supplements, which now adhere to stricter GMPs compared to the past.
The course also features commonly asked interview questions and answers, preparing you for Regulatory Affairs (DRA) interviews. Additionally, as a bonus, there is a software demo titled "General Demonstration and eValidation," guiding you through essential steps in dossier preparation and submission.
With over 26 engaging video modules, this course is structured to simplify complex regulatory topics and walks you through a step-by-step approach to mastering Drug Regulatory Affairs. By the end of this course, you will have the tools and skills to conduct regulatory intelligence and craft a regulatory strategic plan.
I firmly believe that "Quality improvement is a continuous, lifelong process." Upon completing this course, you will emerge as a more capable and respected regulatory professional, equipped with advanced DRA knowledge to make a greater impact within your team, organization, and industry.