Course description
Managing Lifecycle and Variations Effectively
This practical CRED workshop will explain the principles of the EU Variations Regulation. This workshop will also cover intricacies of procedures for grouping and worksharing, and use examples to illustrate the guidelines on categorisation. Other critical actions for effective lifecycle management will be discussed.
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Suitability - Who should attend?
Suitable for
- Less experienced regulatory affairs professionals
- Those who are going into the area of processing/ preparing/ submitting variations
- Regulatory Professionals who would like a refresher in the subject area
Outcome / Qualification etc.
Benefits to participants
- Meet and learn from experts in the field
- Learn by doing- participate in case studies and interactive sessions
- Build a network to support the rest of your career
- Take a course designed by professionals for professionals with a proven track record
- Get pointers about how to strategise the submission of variations to save money and avoid invalidation.
- Gain an up-to-date overview of variation classification and procedures in the EU.
Training Course Content
Day 1
- Introduction to Managing Lifecycle
- Introduction to Variations
- Variation Procedures and their impact on strategy and implementation
Day 2
- Introduction to Renewals & Post-Approval Commitments
- Examples of Lifecycle Planning and Strategy
- Introduction to Case Studies
Expenses
The full tuition price for Members is 925 GBP. The price for Non-members is 1095 GBP
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