Managing regulatory change for filing variations is a complex and challenging procedure. The regulatory requirements highlight the need for successful variations strategies across regulatory teams. It is therefore important for you to understand the regulations, definitions, and best practice for implementation.
This course will teach you how to optimise your procedures for faster, streamlined and compliant variation submissions. The course contains exercises and case studies to help you understand the variation requirements and meet your regulatory goals. You will examine the various types of variations from mutual recognition to type II and centralised procedure variations. You will also discuss how best to approach grouping and worksharing so you know when to apply it to your variations.
LIVE ONLINE TRAINING COURSE
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
Students will learn through:
- Live interactive sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions two days prior to the course start date. If you have any questions please contact email@example.com.
What will you learn?
Formulate variation procedures that achieve faster approval
Manage the practical hurdles of submitting your variations on time and with the right supporting data
Impact of the CTD
Understand the impact of the CTD on your variation dossier
Streamline your variation procedures for international applications
Type II variations
Tackle the challenges of type II variations under the MRP
Who is this course for?
This course will be beneficial to Regulatory Affairs personnel who take part in filing variations such as:
- Regulatory Affairs
- Dossier registration department
- Product Information
- RA compliance
- Personnel from other disciplines who have an impact on the process of filing Variations, such as manufacturing, development, clinical safety and pharmacovigilance.