DUBLIN–(BUSINESS WIRE)–The “Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course (Mar 2nd – Mar 3rd, 2026)” training has been added to ResearchAndMarkets.com’s offering.
Understand 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 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.
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 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
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.
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Key Topics Covered:
Day 1
Introductory overview
- Regulatory agencies in the EU and the 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 devices 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 the medicinal product directive
- Article 117
Documentation requirements
- Preparing regulatory submissions for drug/device and device/drug combinations
- General Safety and Performance Requirements (GSPR) checklist
Day 2
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 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
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
For more information about this training visit https://www.researchandmarkets.com/r/3gcfku
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
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