Post-Approval and Marketing Activities is a comprehensive course that covers the essential aspects of pharmacovigilance, safety reporting regulations, and requirements for post-approval drug and medical device marketing activities. The course is designed for regulatory affairs professionals and other stakeholders involved in post-approval activities.
The course begins with an overview of pharmacovigilance, including the principles, guidelines, and regulatory requirements for monitoring and reporting adverse drug reactions (ADRs). Participants will learn about the role of pharmacovigilance in ensuring patient safety and how to comply with regulatory requirements for safety reporting.
Next, the course will cover post-NOC changes, including safety and efficacy updates, supplements, and level III changes. Participants will learn about the regulatory requirements for making these changes and the documentation required for submission to regulatory agencies.
The course will also cover the Drug Master File (DMF), which is a critical component of post-approval drug marketing activities. Participants will learn about the contents of a DMF, its importance in regulatory compliance, and the process for submitting and maintaining a DMF.
The course will also include an overview of Annual Notification requirements for post-approval drug marketing activities. Participants will learn about the timelines and regulatory requirements for submitting annual notifications to regulatory agencies.
Medical devices post-marketing activities will also be covered in the course, including timelines, fee structures, and reference back to MDSAP and act/regulations guidance documents. Participants will learn about the regulatory requirements for post-approval medical device marketing activities, including license amendments and the documentation required for submission.
Learning Points:
By the end of the course, participants will have a comprehensive understanding of post-approval and marketing activities for drugs and medical devices, including pharmacovigilance, safety reporting regulations, and requirements, post-NOC changes, DMF, annual notification, and license amendments. Participants will gain practical skills and knowledge that they can apply to their work in regulatory affairs.
