Course description
Introduction to Pharmaceutical Regulatory Affairs (Spring edition)
TOPRA's Introductory Courses have been designed to provide a firm foundation to your career in regulatory affairs. It is the most comprehensive of its kind and is presented by speakers and facilitators from industry and agencies, all respected authorities in their field.
Our four-day Spring Introductory Course covers all aspects of the product development process and provides a sound overview of EU legislation and regulatory procedures, plus explores the central role regulatory affairs plays in modern healthcare companies and the development cycle of new drugs. This course is essential for:
- People new to regulatory affairs who want to acquire a strong foundation
- Regulatory professionals wishing to broaden or update their knowledge
- Allied professionals moving into regulatory affairs
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Upcoming start dates
Suitability - Who should attend?
Suitable for
This course is essential for:
- People new to Regulatory Affairs who want to acquire a comprehensive foundation
- Regulatory professionals wishing to update their knowledge
- Allied professionals wanting to understand the role of Regulatory Affairs
Outcome / Qualification etc.
Benefits for participants
- Four interactive days with comprehensive range of topics and case studies
- Develop a network to support the rest of your career
- Meet and learn from an international speaker panel from agencies, industry and contract houses
- High quality course materials
- Gain the practical skills to be a highly effective regulatory professional
- Industry-wide recognised programme will be an excellent start to you career
Training Course Content
- Welcome & Introduction to the course
- New Product Development, The European Regulatory Environment & the Role of Regulatory Affairs
- Overview of the MAA
- Chemical Development/Quality
- Pharmaceutical Development/Quality
- Module 3. An Agency Perspective
- Case Study 1. Chemistry & Pharmacy
- Understanding the Need for Non-Clinical Safety Studies
- The Importance of Pharmacokinetics & Pharmacodynamics in Drug Development & Registration
- The Components of the Non-Clinical Section of a Marketing Authorisation Application
- Clinical Drug Development, Paediatric Investigation Plans & the link with Regulatory Affairs
- The Regulation of Clinical Trials in Europe – An Agency Perspective
- The European Clinical Trials Process – Industry Perspective
- The Components of the Clinical Section of a Marketing Authorisation Application
- Case Study 2: Non-Clinical & Clinical Development
- EU Procedures and the Factors for Success – My Experience as a Pharmaceutical Assessor and Unit Manager
- The Centralised Procedure - Practical Industry Experience
- The Mutual Recognition Procedure & the Decentralised Procedure – Practical Industry Experience
- Generic Applications & Biosimilars
- Regulatory Strategy Session Part 1
- Regulatory Strategy Session Part 2
- Case Study 3. Regulatory Strategy
- Lifecycle Management – Quality
- Lifecycle Management - Safety & Efficacy
- Product Information – Regulation of the SmPC, PIL & label
- Accurate, Balanced, Clear? The ABC of Medicines Advertising
- Case Study 3. Variations
- Health Technology Assessment: Why and where does the regulatory professional become involved?
- An Introduction to Biotechnology & Advanced Therapy Medicinal Products
Expenses
The full tuition price for Members is 2690 GBP. The price for Non-members is 3010 GBP