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
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.
Postgraduate Level 7
€ 2.000,- (plus VAT)
€ 2.380,- (incl. 19% VAT)
The VAT rate of 16% applicable from 1 July to 31 December 2020 shall apply to courses which are completed by the course participant according to schedule by 31 December 2020. In all other cases a value added tax of 19% is due.
Certificate of the College of Medicine and Dentistry (Birmingham) with 10 ECTS
Start: Monday 14th Sept 2020
Dates 2021: The course will start in January and May 2021.
For Privat Persons
This course cannot be booked directly by private persons. If you are an employee of a company and would like to take this course, please contact your supervisor or your human resources department so that they can book the course at Springer Campus for you.
Companies can book this course for their employees directly at Springer Campus: