Dublin, Sept. 06, 2024 (GLOBE NEWSWIRE) -- The "Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course" conference 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 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 websiteprior 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 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.
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Day 1
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
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
Speakers:
David Jefferys
Senior Vice President
Eisai
Dr David Jefferys is currently Senior Vice President with Eisai responsible for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia). After qualifying in medicine 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, joint CEO of MHRA. He was involved in the establishment of the European Medicines Agency, CPMP/CHMP member and MRFG and PER scheme chairman. For the last ten years he has worked in industry and chairs several key committees for ABPI, Efpia and IFPMA. He has lectured and published extensively in drug and device regulation and on benefit risk evaluation.
Tina Amini
Pharmacist
Aston University
Dr. Tina Amini is a pharmacist with a PhD in Pharmaceutics from Aston University. She joined Lloyd's Register as Senior Technical Specialist in 2018. She has previously worked at BSI as the lead Pharmaceutical Expert and Combination Product Specialist for several years.
Tina has been involved in the classification of borderline products and consultation process with several EU competent authorities for device/drug products. Prior to joining Notified Bodies, Tina worked in the Pharmaceutical Industry for over 17 years in a variety of disciplines where she took products through from discovery to commercialisation.
Jonathan Hughes
J.Hughes
Jonathan Hughes, Ph.D., FTOPRA, has over 32 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). Jonathan has experience of regulating medical devices and combination products across most international markets including the European Union, US, Japan, China, Canada and Australia.
Jonathan specialises in regulatory strategy, regulatory and clinical development pathways, worldwide regulatory submissions and training. He has a strong knowledge of quality management systems and has direct hands-on experience of EU NB, MDSAP, US FDA, Brazilian ANVISA and Chinese NMPA inspections. He has worked with all the major international regulatory agencies, in particular (multiple) Notified Bodies and EU Competent Authorities, Japanese PMDA, US FDA, Chinese NMPA.
Jonathan has served on two European Commission Expert Working Groups on the Drug / Device Borderline and Device Classification. Jonathan is a Fellow of the regulatory professional organisation, TOPRA, and is a regular contributor on numerous educational and training programmes. Jonathan has registered teacher status at Cranfield University, is a Visiting Industrial Fellow at the University of Hertfordshire and also a visiting lecturer at University of Newcastle upon Tyne.
Andrew Willis
Consultant
Independent
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. Catalent is the world's leading contract manufacturer and distributor of pharmaceuticals, and 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 has 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 currently has a total of 28 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. Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.
For more information about this conference visit https://www.researchandmarkets.com/r/bezemj
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