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
- 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.
• Pharmaceutical Regulatory Science
• Pharmacology I
• Pharmacology II
• Animal Toxicology and Pharmacology
• ADME I
• ADME II
• ADME III
• Stability and Formulation Testing
• Is Biopharm the Future of the Pharma Industry?
• Monoclonal Antibodies
• Regulatory Affairs
• Drug Regulation and the Agencies
• Regulatory Requirements during Drug Development and Marketing Approval
• Structure of Marketing Authorisation Applications and the role of ICH
• Chemistry and Manufacturing Control and New Regulatory Approaches to Quality
• Post-Approval Regulatory Affairs
• Intellectual Property and Lifecycle Considerations of Pharmaceutical Products
• Principles and Practice of Marketing
• Medical Information and the Regulations
• The Country Medical Dept
• Emerging Issues in Pharmaceutical Development
Contact | Registration
If you have any questions, please feel free to contact me.
Dr. Benjamin Steeb
Tel.: +49 (0)6221 / 487 – 8054
For registration please use our quick & easy registration form:
Date | Price | Audience
Duration | Workload | Certificate:
4 weeks | 30 hours of tutor guided learning activities | Certificate of completion by Healthcare Learning
€ 1.000,- (plus VAT)
This course can be booked by private persons as well as by companies.
For Privat Persons:
Please register via our registration form.
Companies can book this course for their employees directly at Springer Campus. For further information please visit our company page.