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 | Information material
For further information about our in-house seminars, company terms and conditions or questions regarding our content please get in touch with us via email, phone or the contact form. We would also be pleased to send you our 'Offers for companies' information brochure. We look forward to hearing from you.
Director Distance Learning
Tel.: +49 (0) 6221 487 8061
Please contact me directly or use the quick & easy
Contact form for corporate customers
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)
Companies can book this course for their employees directly at Springer Campus. If you are an employee of a company and would like to take this course, please contact your HR department so that they can book the course for you at Springer Campus.