Management Forum Logo

Presented by
Management Forum

Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course

Practical guidance complex regulatory landscapes of EU and FDA for drug/device & device/drug combination products in this comprehensive course.

17-18 September 2024
+ 21-22 January 2025, 19-20 May 2025, 10-11 September 2025 »
from £1099

Need help? Enrol or reserve

Format: Live online
CPD: 12 hours for your records
Certificate of completion

Download Print Enrol or reserve

Course overview

This course has been designed to provide regulatory affairs professionals with a deep understanding of the regulatory frameworks governing drug/device and device/drug combinations in the European Union and the USA.

The demarcation between medicinal products and devices is becoming ever more important and, with the convergence of emerging novel technologies, the number of drug/device combination products and medical devices incorporating a medicinal substance is increasing. At the same time, cell therapy and tissue-engineered products are being combined with both pharmaceuticals and medical devices. This course will address the European and FDA regulatory requirements, help you define the regulatory route for your product and offer practical guidance on Notified Body expectations, clinical trial considerations and post-market surveillance of borderline products.

Participants will have an invaluable opportunity to discuss the complex issues involved with key regulatory experts in this field.

By the end of the course participants will have the knowledge and skills needed to navigate the complex regulatory landscape for drug/device and device/drug combinations in the EU and the USA effectively. They will be equipped to ensure compliance with the regulatory requirements and facilitate the successful development and commercialisation of these innovative products.

PRE-SEMINAR READING - It is recommended that you have read the the EU Medical Device Regulation, particularly, Article 120 and the General Safety & Performance Requirements (Annex I) and Technical Documentation (Annexes II and III). For the US, review FDA’s Office of Combination Products website prior to attending this seminar.

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Benefits of attending

Understand the European regulatory guidance
Know what your competent authority expects
Gain an insight into notified bodies considerations on drug/device products
Learn how to define the approval route for your product
Clarify the major differences in documentation and approval routes
Consider quality systems requirements for combination products
Discover the FDAs regulatory approach to combination products
Hear how to deal with human tissue engineered products
Stay up-to-date on post market surveillance for combinations products

Who should attend?

Development and regulatory personnel in the medical device, pharmaceutical and diagnostic industries, who need to understand the complex requirements applicable to medical devices incorporating ‘pharmaceutical’ ingredients, or pharmaceutical products incorporating a device or delivery system.

Enrol or reserve

The Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products course will cover:

Day 1
Day 2

Introductory Overview

Regulatory agencies in the EU and USA
Impact of the revision to the MDD
Transitional period from the MDD to the MDR
EU Regulatory reform proposals
EMA’s viewpoint management
Evolving regulatory landscape
Emerging trends

European Regulatory Guidance: Drug/Device and Device/Drug Combination Products

European regulatory framework for drug/device and device/drug combinations
Legal EU definitions of a drug/device and device/drug combination
Article 117: EU Requirements for Integral drug/device combinations
‘In exclusive use with’
Other combinations – AI systems etc.

European Regulatory Guidance Continued

Risk management and compliance strategies
Interactions with regulatory agencies and stakeholders
Best practices for navigating the regulatory landscape

Defining the Regulatory Approval Pathway for your Product

Product classification
Differences between device containing ancillary medicinal substances and medicinal products
Responsibilities of regulatory affairs professionals in product development commercialisation

Medical Device CE Certification – Notified Body Expectations

CE marking process for medical devices
Devices containing ancillary medicinal substances
Post CE marking expectations and changes
Notified Body Opinion (NBOp)

MDR’s Impact on Medicinal Product Directive

Article 117

Documentation Requirements

Preparing regulatory submissions for drug/device and device/drug combinations
General Safety and Performance Requirements (GSPR) checklist

Clinical Trial Considerations

How the regulatory pathway for the final marketed product determines the clinical trial regulation to be followed
Clinical Trials Directive 2001/20/EC – medicines
Requirements for clinical development of medical devices
Clinical data requirements and post-marketing surveillance

Product Information

Labelling requirements under the MDR
Labelling for combination products
Electronic Product Information (ePI)

Companion Diagnostics

Regulatory Considerations

UK Post Brexit

UK IRP: International Recognition Procedure

Pharmacovigilance for Combination Products: Vigilance of Pharmacovigilance

Understanding the differences between medical device vigilance and pharmacovigilance
How to handle the challenges posed by combination products
Pharmacovigilance reporting
Device vigilance reporting

FDA’s Approach to Combination Products

Background and legal framework
Definitions of drug, biologics and medical device
"Borderline" issues and products (v. combination products)
Types of combination products
Primary mode of action and FDA's assignment algorithm
Jurisdiction and designation process

FDA's Approach to Combination Products (continued)

Submission and regulatory pathways
Current GMP and quality system requirements
Post-market safety reporting requirements
Strategies for development and summary points

Enrol or reserve

David Jefferys
Eisai

Dr David Jefferys is Senior Vice President for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia) at Eisai. After qualifying, he worked in clinical and academic medicine before spending 20 years as a senior regulator for both medicines and medical devices.

He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA and joint CEO of the MHRA. He was involved in the establishment of the European Medicines Agency, is a CPMP/CHMP member and Chair of the MRFG and PER scheme. For the last ten years he has worked in industry and chairs several key committees for ABPI, EFPIA and IFPMA.

More details

Tina Amini

Dr. Tina Amini, a pharmacist with PhD in Pharmaceutics. She has over 30 years experience in Pharmaceutical and Medical Devices. She previously held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at bsi Notified Body, where she was responsible for Device Drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management System (QMS) as the lead auditor.

Tina has extensive experience of regulatory expertise for CE marking of medical devices, and has been involved in the classification of borderline products and consultation process with several EU competent authorities and EMA for device/drug products.

Prior to joining Notified Bodies, Tina worked in the Pharmaceutical Industry in a variety of disciplines where she took products through from discovery to commercialisation.

More details

Jonathan Hughes
JHRA Ltd

Jonathan Hughes, Ph.D., FTOPRA, has over 35 years of worldwide regulatory and clinical affairs experience across medical devices, drug / biologic – device combination products and in-vitro diagnostics. He has worked with medical device and pharmaceutical companies, both large and small, across multiple locations to help develop and execute regulatory strategies for market clearance, approval and access.

Jonathan has hands-on experience in a variety of therapeutic areas and has worked across different technologies and types of medical products including medicated devices (devices containing ancillary drug and biologic constituents), drug delivery systems and componentry, sterile and non-sterile disposables and durable equipment, in-vitro diagnostics, software controlled devices and standalone software (including mobile apps). He has experience of regulating medical devices and combination products across most international markets including the European Union, US, Japan, China, Canada and Australia.

More details

Andrew Willis
San Salvatore Training Ltd

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

17-18 September 2024

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 14503

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 13 Aug

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

21-22 January 2025

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 15209

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 17 Dec

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

19-20 May 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15210

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 14 Apr

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

10-11 September 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15211

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 06 Aug

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.