Enrol Before | 10 March To Save £400 | 19 April To Save £200
Discount has been applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,595 and live online is £1,295.
Course Overview
Combination products pose regulatory difficulties as the requirements of medical devices must merge with pharmaceuticals and biotech. As biotech and advanced therapeutics grows, so too does the need for specialised device delivery systems resulting in an increase in combination products. Similarly, device companies are increasingly adding medicinal substances to improve products.
This combination product training course provides you with the skills and knowledge to navigate both the pharmaceutical and device regulations. You will examine the regulatory pathways for drug/device and device/drug products. You will examine small molecules, large molecules and ATMPs in combination with devices. Importantly, you will learn how to merge the two regulatory systems in areas such as risk management, quality and clinical.
This course is delivered by two experts. Richard is an experienced regulatory and quality professional for medical devices and IVDs. Andrew is a leading expert in regulatory affairs and quality for pharmaceuticals, biotech, biosimilars and ATMPS. With both experts you will gain practical insights into developing a successful combination product strategy.
You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. You can decide whether you would like to attend in person or online. The price is dependent on the option.
There are limited spaces on the introductory session. 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.
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
Module 1
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
Module 2
Device regulations in the EU and US
Overview of the current regulatory framework for medical devices in the EU
Roles of Competent Authorities (CA) and Notified Bodies (NB)
Impact of the Medical Device Regulation (MDR) on combination products
Examine the regulatory framework for devices in the US
Review 21 CFR Part 3 and Part 4
Office of Combination Products (OCP)
RFDs (requests for designation) and Pre-RFDs (pre-requests for designation)
Module 3
Risk management and labelling
Examine risk management:
Overview of Standard ISO 14971
Risk management for a combination product
Review labelling:
Brief overview of labelling requirements
Labelling for combination products
Module 4
Design and development challenges
Expectations when designing and developing a medical device
Development consideration for a combination product
Perspectives by constituent part
Human factors
Module 5
Clinical and post market obligations
Clinical evaluation for devices
Clinical requirements for medicinal products
PMS requirements for medical devices
Pharmacovigilance requirements for medicinal products
Module 6
Regulatory affairs for pharmaceuticals
Overview of the regulations
Pharmaceutical quality management
Merging the two regulatory systems
Examine best practice to merge both regulatory systems together
Examine how to merge both quality systems
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.
This course is suitable for professionals who work with drug/device combination products. It is ideal for pharmaceutical professionals who are combining a device with their medicinal product. Likewise, it is suitable for device professionals who are looking to add a medicinal element to their product.
These include medical device and pharmaceutical professionals in the following roles: Regulatory Affairs | Quality | Design & Development | Clinical | Management.
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
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
17 March 2023 | 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
10 May 2023
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
11 May 2023
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.
This course is suitable for professionals who work with either drug/device or device/drug combination products. It is ideal for pharmaceutical professionals who are combining a device with their medicinal product. Likewise, it is suitable for device professionals who are looking to add a medicinal element to their product.
These include medical device and pharmaceutical professionals in the following roles:
Regulatory Affairs
Quality
Design & Development
Clinical
Management.
Most of our classroom courses are located at a venue in central London. The city has good transport links and is good place to socialise with fellow attendees. Accommodation is not included in the price. We recommend staying in a hotel within walking distance of the venue. Lunch and refreshments are included on all days where you will be able to interact with fellow peers and the trainers.
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Complete our contact form by following the link. Get in touch.
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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• In the event we do not have enough people on one of the options we will contact you to discuss switching. If for example we ask you to switch from classroom (in-person) to live online, we will refund you the difference in price.
