Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Module 1

Overview of Regulations 1234/2008 and 712/2012 in Europe

• Classification in accordance with the legislation
• Understand the differences between Type lA, Type IB and Type ll variations
• Clarify foreseen and unforeseen Variations
• Sharing practical experience with European and national procedures

Module 2

Examining grouping and work-sharing

• Understanding when grouping is appropriate
• Clarifying what types of variations may be grouped
• Guidance on assembling a grouped submission
• Understanding when work-sharing is appropriate

Module 3 & 4

Submitting a variation

• Identify and understand strategic considerations
• Handling active ingredient master files as variations
• Submission of new clinical data
• Practical session: Analysing and classifying the different changes
• Data requirements for type II variations
  • Learn how to identify and support a type II change
  • Practical session: Data requirements for more complex changes
• Understanding Module 3 and the dossier impact on variations

Module 5

Filing strategy

Understanding the following FDA review options:

• Creating a global dossier (gold/silver/ bronze versions)
• Understanding implementation and grace periods
• Fixed and rolling implementation strategy
• Practical session: Plan the timelines/project management of a variation submission

Module 6

Variations through national procedures and differences from centralised procedure

• Understand the procedures
• Languages and translations
• Explore the linguistic review process

Module 7

Mutual recognition and decentralised procedures for variations

• Understand the procedures and responsibilities of the MAH, RMS and CMS
• Learn how to efficiently plan for and run an MR variation procedure
• Practical session: A variation to an example MRP authorised product including planning timelines and impact of referrals

Module 8

Examining other procedures

• Article 5
• Urgent safety restrictions
• Understanding when to use extension applications

Advanced compliance

• Creating your own compliance requirements
• SUPAC guidance

Andrew Willis is a regulatory and Development consultant with 30 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.

Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Andrew’s experience covers multiple applications, scientific advice meetings and orphan drug applications. He has significant experience with novel drug delivery systems has been utilized in all the above type of applications.

Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. He currently delivers extensive training courses available in Quality By Design, Global Module 3 Requirements and Optimizing the Life of Your Products. Andrew has delivered multiple courses on lifecycle management, specifically filing variations. He has extensive experience of managing marketing authorisations of a range of products such as biotech, small molecules and more recently advanced therapies (ATMPs), specifically cell therapies.