DUBLIN–(BUSINESS WIRE)–The “Drug/Device and Device/Drug Combinations in the EU and USA 20” conference has been added to ResearchAndMarkets.com’s offering.
This seminar 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.
Practical Guidance on Borderline Issues and Combination Products
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.
PRE-SEMINAR READING: It is recommended that you have read the Medical Device Directive, Essential Requirements Annex 1 and 3 and the relevant sections on combination products in the new Medical Device Regulation prior to attending this seminar.
Benefits of Attending
- Understand the European regulatory guidance
- Know what your competent authority expects
- Gain 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 FDA’s regulatory approach to combination products
- Hear how to deal with human tissue-engineered products
- Stay up-to-date on post-market surveillance for combination products
Agenda
Programme Day One
Chair’s welcome
- Dr David Jefferys
Introductory overview
- Background
- Life cycle management
- Exclusivity
-
Patents
- Dr David Jefferys
European regulatory guidance
- Life expectations of a competent authority
- Impact of the revision to the MDD
-
EMA’s viewpoint management
- Dr Elizabeth Baker
Panel discussion
- EU regulatory requirements
Defining the regulatory approval route for your product
Product classification
-
Differences between device containing ancillary medicinal substances and medicinal products
- Dr Tina Amini
Medical device CE certification – Notified Body expectations
Devices containing ancillary medicinal substance
- Devices containing ancillary human blood derivative
-
Post CE marking expectations and changes
- Dr Tina Amini
Highlights of major differences in documentation between:
- Device
- Drug and device
-
Device and drug
- Dr Tina Amini
Quality and non-clinical considerations for combination products
- Quality, pre-clinical and biocompatibility issues and how to address these for combination products
-
What kind of non-conformance can we expect if you combine a drug and device?
- Dr Tina Amini
Discussion session
Programme Day Two
Review of day one
- Dr David Jefferys
Clinical trial considerations
- How the regulatory pathway for the final marketed product determines the clinical trial regulations to be followed
- Clinical Trials Directive 2001/20/EC – medicines
- Requirements for clinical development of medical devices
-
Clinical data requirements and post-marketing surveillance
- Dr David Jefferys
FDA’s approach to combination products
- Requirements for product assignment, pre-market review and post-market regulation
- Good manufacturing practice (GMP) regulation
- Resources and guidance documents
-
Hints and tips on good approaches Mark Kramer
- Mark Kramer
Panel discussion
- Compare and contrast EU and USA regulations
Human tissue-engineered products
- What are tissue-engineered and advanced therapy combination medicinal products?
- How are these new borderline products regulated in the EU and US?
- What are the practical challenges with the development of these products?
-
Impact of the proposed regulation on medical devices
- Alison Wilson
Companion diagnostics
- How the regulatory guidance impacts companion diagnostics
-
What to consider
- Dr David Jefferys
Post-market surveillance for combination products: vigilance or pharmacovigilance?
- Understanding the differences between medical device vigilance and pharmacovigilance
- How to handle the challenges posed by combination products
- Pharmacovigilance reporting
-
Device vigilance reporting
- Dr David Jefferys
Discussion session
For more information about this conference visit https://www.researchandmarkets.com/r/pufcya
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900