Post Graduate Award in Regulatory Affairs
Regulatory Affairs covers the key regulatory and medical affairs issues affecting the industry today from an overview of the major drug regulators and the requirements during drug development to medical information and regulations including prescribing issues to life cycle management issues.
Key Information
Further Details
Key Information
Application Status
Open for Sept 2020
Dates 2021: The course will start in January and May 2021.
Study Mode
Flexible study concept with self-study and live webinars
Certificate with exam and 10 ECTS
Duration
12 weeks
300 hours: 30 contact hours (live webinars) and 270 of directed self-learning
Course Fee
€2,200 or early bird price: €1,950
Course Leader
Dr. Peter Caetano
Further Details
Course contact for further information
Loji Thebe
T: 0121 345 9847
E: admission@comd.org.uk
Awarding Institution
College of Medicine and Dentistry
Course Details
Course Details
Entry Requirements
Topics
Course Details
After successfully completing this course, students will be able to:
- Evaluate the regulatory issues affecting the pharmaceutical industry
- Compare the regulation of medicines in different global markets, specifically in the EU and MENSA area
- Develop and critically appraise product-related information to ensure adherence to ethical and legal provisions.
- Compare and evaluate the different roles of Regulatory and/or Medical Affairs departments to propose consistent strategies involving the marketing of pharmaceuticals, medical information, the role of a pharmaceutical company’s country medical department and licensing agreements.
Entry Requirements
The entry requirements for the course are:
(a) A level 6 degree in Pharmacy, Biomedical science, Medicine or equivalent,
(b) Competence in written and spoken English
Topics
- Regulatory Affairs in the EU and in MENSA
- Strategic planning in regulatory affairs
- Regulatory strategy for a New Active Substance
- Leadership and Strategic Management in Regulatory Affairs
- Data Management and Digitalisation in Regulatory Affairs
- Pharmaceutical Regulatory Science and the role of agencies
- Absorption, distribution, metabolism and excretion (ADME) and role in drug regulations
- Drug Development and the Marketing Approval Process
- Intellectual Property and Lifecycle Considerations of Pharmaceutical Products
- Principles and Practice of Marketing
- Medical Information and the Regulations
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