Guest Lecture on Regulatory Publishing

The COSMETIC CLUB, in collaboration with the Department of Pharmaceutics at MB School of Pharmaceutical Sciences, successfully organized a highly informative guest lecture on “Regulatory Publishing”. The session, held on November 7, 2024, was graced by the presence of Mr. Shaik Mohammed Ezaz, a Senior Regulatory Associate at Parexel, Bangalore, whose expertise in the field brought invaluable insights to the attendees. Mr. Ezaz delivered a comprehensive presentation highlighting the pivotal role of regulatory publishing in the pharmaceutical and life sciences industries. He emphasized its significance in ensuring compliance with global regulatory standards—an essential step for achieving drug approvals and facilitating market access worldwide.

The lecture delved into various aspects of regulatory submissions, including:

• Documentation Requirements: An overview of essential documents required by major global regulatory authorities such as the FDA, EMA, and ICH.
• Electronic Submissions: An in-depth discussion on the industry’s transition to the electronic Common Technical Document (eCTD) format, a revolutionary change that has streamlined submission processes and enhanced efficiency.

Mr. Ezaz also illuminated the technical intricacies of regulatory publishing, covering critical topics such as:

• Document preparation, formatting, and review.
• The importance of accuracy, consistency, and meticulous attention to detail in crafting regulatory dossiers.

In addition, the session offered a glimpse into the future of regulatory publishing, exploring emerging trends like:

• The increasing use of automation and digital tools in the submission process.
• Adaptation to evolving regulatory frameworks and the challenges these bring.

This interactive and thought-provoking session received an overwhelmingly positive response from the attendees, who praised the clarity, relevance, and depth of the content presented. The event not only enhanced their knowledge but also provided a clearer perspective on the challenges and opportunities in this specialized field.