Post Graduate Award in Regulatory Affairs
- Flexible study concept with self-study and live webinars
- Certificate with exam and 10 ECTS
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.
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.
Topics covered in the course:
• 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
Schedule of the live webinars
All live webinars will be recorded and can be viewed again at any time and as often as you like. So if you have missed one of the webinars it is no problem. If you have any questions you can contact the speaker or simply ask your questions in the next live webinar.
Your benefits of the live webinars
✔ Location independent
✔ Participate live or watch the webinar later at your own leisure
✔ Ask your questions directly to the speaker
✔ Discussion with other participants
The schedule will be published soon.
Peter Caetano is Ipsen's Global Regulatory Affairs Senior Director in Oxford. He teaches at the College of Medicine and Dentistry, Univ. Ulster, N. Ireland.
Dr. Caetano is team leader for scientific advice and submissions worldwide for novel biologicals. he was EU Sr. reg. manager at Allergan, Latin America reg. manager at Genzyme-Sanofi, and US reg. manager at P&G. Caetano liaises with FDA, EMA, ANVISA, etc. bringing medicines to market. Peter authors BDs, INDs, CTAs, CTDs, BLAs, MAAs. He masters CMC, preclinical and clinical reg. strategy, with technical expertise in drug development ranging from pharmaceutical biotechnology to clinical endpoint validation.
Peter holds a PhD from Michigan, PharmD from Ohio State, MPH from Harvard, PgDip from Oxford, and MBA from ESSEC-Mannheim.
Cooperation partner: College of medicine & dentistry, Birmingham (UK)
Established in 2018, we are one of the few private education providers offering a wide range of training programmes for the dental team and all healthcare professionals. Working across a blended learning concept, we aim to reach out to all aspiring individuals to improve their knowledge and skills. Our collaboration with Ulster University enables us to offer a wide range of career progression opportunities.
Contact | Infomaterial
For further information about course content, company terms or our in-house seminars please get in touch with us via email or phone. We look forward to hearing from you.
Springer Campus Marketing
Tel.: +49 (0) 6221 487 8428
Registration | Further information about the course
Online (live webinars) and self-directed learning
College of Medicine and Dentistry, Birmingham (UK)
Duration | Workload:
300 hours: 30 contact hours (live webinars) and 270 of directed self-learning.
Level 6 degree in Pharma, Biomed, Medicine or equivalent
English test: The College of Medicine and Dentistry will do an English test (free of charge) internally to the students. The English test will be one hour maximum and will assess the applicant competencies in Speaking, Reading, Writing and Listening. The test will be focused on pharma issues. This will tick the English Language requirements for the course.
€ 2.200,- (VAT-free)
Certificate of the College of Medicine and Dentistry (Birmingham) with 10 ECTS
Start: February 2021 (Registration deadline: 09 February 2021) | May 2021
If you would still like to join after the application deadline, simply contact us and we will check whether you can still join the course.
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