Regulatory Affairs in (Bio)Pharmaceuticals - Professional Diploma

Program Overview

This unique program from industry professionals equips graduates for Regulatory Affairs careers in the biopharmaceutical industry. It covers drug regulation, regulatory interactions, clinical development requirements, and strategies for established substances. Graduates gain a comprehensive understanding of the field and prepare for success in safeguarding patients and streamlining regulatory processes in the pharmaceutical sector.

Program Outline

Outline:

• Drug Regulation & the Agencies:
Introduces the legal basis for regulating medicines in the bio/pharmaceutical industry, improving interactions with Regulatory Authorities, and interpreting current legislation.
• Regulatory Affairs Interactions in Drug Development & Product Marketing:
Informs students about the importance of the regulatory function in drug development and product marketing, providing an overview of the Irish Pharmaceutical Healthcare Association (IPHA) and fundamentals of pharmaceutical development.

Teaching:

• Combines traditional distance education with online learning.
• May include some on-campus tutorials per semester, typically on Saturdays.
• Emphasizes the integration of concepts, tools, and techniques through case studies and group working.

Careers:

• Prepares graduates for careers in Regulatory Affairs within the pharmaceutical, biological, biopharmaceutical, and chemical sectors.
• Provides opportunities for networking and career development through interactions with industry experts and HR professionals.

Other:

• The program is unique in that it is designed and delivered by Regulatory professionals.
• Graduates gain a solid understanding of Regulatory Affairs and its importance in the drug development process.
• The program focuses on safeguarding patients by ensuring the safety, quality, and efficacy of medicines on the market.
• Graduates learn from experts currently working in the field, gaining insights into strategies for improving performance and speeding up regulatory approval time.
• Graduates develop confidence and interview techniques, as well as CV development and career opportunities.

The fee for this programme is €6,500 per annum (EU and NE)