Summary
The challenges associated with drug-device combination products are complicated as they must be registered either as pharmaceutical or medical device products. This course will help you navigate this complicated regulatory landscape. You will return with an understanding of the complex regulatory landscape as it applies to your drug/device combination, including risk management, clinical considerations, and design control.
Learning Objectives
- Understand the regulatory requirements for drug-device, device-drug combinations
- Gain an understanding of the roles of Competent Authorities and Notified Bodies
- Examine best practices for working with medical device suppliers and manufacturers
- Engage new stakeholders and establish new processes
- Establish a control strategy to deliver safe and efficacious products
- Understand design control expectations
Key Topics
- Key definitions
- Regulatory update & pathway (FDA & EMA)
- Notified Body (NB) Review Process
- General Safety & Performance Requirements (GSPR)
- Labeling
- Quality management systems
- Post-market surveillance
Who should attend?
This course is suitable for all those involved in:
- Regulatory Affairs
- Quality Control/ Assurance/ Engineering
- Product Development/ Engineering/ Technology Transfer
- Process Development
- Research & Development
- Production
Past participants
- Global Head External Quality, Biogen
- QA Manager, F. Hoffmann-La Roche
- Senior Manager GLP/GMP, Merz Pharmaceuticals
- Senior Technical Regulatory Affairs Manager, Idorsia Pharmaceuticals
- Senior Technical Steward Devices, Novartis
- Manager, External Manufacturing Management, Ferring
- R&D Engineer, Cook Medical
- Principle Scientist Lead Combination Products, Lonza
- Process Engineer, Novo Nordisk
- Quality Manager, Boston Scientific
- Global DRA Project Leader, Idorsia Pharmaceuticals
- Design Team Manager, Owen Mumford
- Development Engineer, Leo Pharma
- Regulatory Affairs Manager, Novavax
- Head of Regulatory Affairs, Vectura
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Drug-Device Combination Products: Quality & Regulatory Requirements
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
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