Hybrid Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. For classroom attendees, refreshments are served from 8:30 AM. For online attendees, you will receive joining instructions. 

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

Introductory Online Module

FREE to Attend | Live & Recorded

21 March 2024 | 1:00 PM (UK)

Delivered Online

Overview of the regulatory landscape for combination products

• Review the definition of a combination product
• Medicine-device borderline and classification
• Examine the major differences in regulatory affairs between medicines and devices
• Review the regulatory pathway for combination products in the EU and US

Register For Module 1 | Free

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

Day 1

15 May 2024 

Defining a combination product in the EU and US

• Review the definition of a combination product
• Legislation
• EU v US
• Review the regulatory pathway for combination products in the EU and US
• Medicine-device borderline and classification

Development process

• Development considerations for a combination product
• Development overview of medicinal products (small molecule, biotech & ATMP)
• Development overview of medical devices

Workshop

In this workshop you will review and analyse various borderline classification examples.

• Latest version of borderlines
• In groups you will examine and review examples to work on
• Discuss EU and US regulatory processes

Understanding Medical Devices

• The EU Medical Device Regulation
• UK regulatory landscape
• CE Marking and Notified Body Interaction
• Labelling
• Vigilance
• Roles of Competent Authorities (CA) and Notified Bodies (NB)
• Impact of the Medical Device Regulation (MDR) on combination products

Medical devices technical file

• What is required?
• Structure
• Clinical and post market obligations for your device
• Review biocompatibility
• Risk management
• Human factors

Day 2

16 May 2024 

GMP / ISO standards

• Key questions and practical implications
• Examine how to merge both quality systems
• Interpretation of standards
• EU v US

Medicinal regulatory submissions

• Examples of small molecules, biotech and ATMPs will be used throughout
• Understanding the CTD – Common Technical Document
• Data Expectations withing the CTD
• Examine all five modules of the CTD M1-M5
• Where to place information, specifically for combination products
• Deep dive into module 3 of the CTD – CMC, quality guide for combination products
• CQA Pyramid

NB opinion for drug/device

• Examining MDR Article 117
• Reviewing the Notified Body (NB) preliminary assessment for drug/device products
• What do NB’s want to see?

Key Considerations for regulatory strategy

• Deciding a regulatory route
• Considerations for small molecules, large molecules and ATMPs
• Device/Drug registration
• Drug/Device registration
• Labelling

Andrew Willis is a Regulatory and Development consultant with 35 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies 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. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of 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. More recently for IO Biotech, Andrew was SVP of Quality, Regulatory and CMC sitting on core C-suite providing CTO support activities – overseeing all pharmaceutical development of drug substance and drug products for peptide molecules and ensuring appropriate quality systems are in place.

 

He currently delivers extensive training courses available in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.

Richard Young has over 20 years’ experience in the medical device and IVD industry with products such as class 3 implants to combination products. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

 

Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.

 

Richard has delivered both online and classroom training courses on drug/device combination products. He has supported many professionals with their understanding of the regulatory framework in both the US and EU. Drawing on his extensive industry experience, Richard provides examples and case studies during the training.