Labelling as Driver for Regulatory Strategy

• Target Product Profile, Core Company Data Sheet, Product Information and Regulatory Intelligence
• Intellectual property rights - when does various scenarios matters regulatory vice,
• Regulatory strategy – Get your message through
• Patient reported outcomes, health economics and market access factors - regulatory, strategic relevance
• Patient involvement and perspectives in Product Information
• Industry and health authority aspects on real world data and real world evidence  

You will be able to understand the need for justified documentation based on context rather than assumptions. This scientific approach facilitate sound and transparent regulatory decision-making; enables you to challenge specialists; and argue for the relevance and scientific legitimacy of context-based documentation.

This course enables your company to take the regulatory lead from early in the research and development phases throughout the approval and strategic regulatory life cycle phases. Your company will gain a regulatory professional, who are able to challenge the regulatory systems, supportive legislation and guidelines to ensure a strong story line for health authorities. Thereby preventing delays in drug innovation, approval and in the market access with regard to the regulatory part.

Innovate and strengthen the regulatory process  

The course is intended for regulatory affairs specialist employed in industry, regulatory agencies or consulting.

Participants must

• Hold a relevant bachelor degree or equivalent
• Have a minimum 2 years of relevant job experience
• Be proficient in English

Find detailed information about the admission criteria.

A steep learning curve

With a background as a biomedical scientist, Ridhirama Bhuwania didn’t know much about regulatory strategies beforehand.

“I applied to the course out of personal interest and a wish for personal development, but it has also given me some great tools for my further career. If I ever want to go into a leadership role, this course will be really helpful for me, since it allows me to better understand how market access and regulatory affairs interact with each other.”

“With a greater knowledge of the what’s, why’s and how’s, I feel much more well equipped for a future in regulatory affairs and strategies. In the pharma industry, it’s important to understand how every part of the chain contributes to the processes that the products go through,” she says.

Ridhirama Bhuwania especially compliments the structure and the teachers of the course;

“I liked how the course started with an overview and the basics of the subject, and then quickly moved deeper into each and every topic of regulatory strategy. With great speakers, group assignments and workshops, the interactive learning environment made for a very steep learning curve,” she says.

“If you have a personal interest in the bigger picture of regulatory affairs and its functions, I would definitely recommend this course.”

This course is offered as a compulsory part of Master of Medicines Regulatory Affairs.

Priority is given to students enrolled on Master of Medicines Regulatory Affairs. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.