Learn the key factors of successful drug/device combination products to ensure a more efficient approval process
Course Overview
Drug/device combination products present unique challenges. Under EU law, combination products must be registered as either pharmaceutical products or medical devices. For drug/device combinations, significant problems can arise in understanding an unfamiliar regulatory environment, product design, corporate collaborations, and much else. This essential course provides useful insights into requirements for devices to improve your understanding of additional aspects to be incorporated into your dossier.
On this course, you will work with our experienced trainer to understand the medical device world as it applies to your drug/device combination, including risk management, clinical considerations, and design control. The course will also feature a session on collaborating with partners in the device world to improve outcomes for your products. There will also be additional time for delegates to discuss the implications of Brexit on this subject matter.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3 hours online.
Over 4 days students will learn through:
- 现场互动bitesize sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contactlifesciences-training@informa.com.
What will you learn?
Key Definitions
Key Definitions
Comprehend how combination products are defined and classified
Regulatory Landscape
Regulatory Landscape
Understand the regulations for drug/device combination product
Competent Authorities
Competent Authorities
Gain an understanding of the roles of Competent Authorities and Notified Bodies
CE Marking
CE Marking
Learn about CE marking for separate devices in drug/device combinations
Labelling Requirements
Labelling Requirements
Compare labelling requirements for medical devices and pharmaceutical products to consider how labelling concerns may be different for combination products
Medical Device Manufacturers
Medical Device Manufacturers
Examine best practices for working with medical device suppliers and manufacturers
Clinical Trials
Clinical Trials
Consider special requirements for clinical trials for combination products
Risk Management
Risk Management
讨论如何集成风险管理approach
Control Expectation
Control Expectation
Understand design control expectations
Pharmacovigilance
Pharmacovigilance
Consider Pharmacovigilance requirements
Who is this course for?
This course is designed for professionals from the pharmaceutical industry who wish to gain a greater understanding of drug/device combination products, including:
- Regulatory Affairs
- Quality Assurance
- CMC
- R&D
- Project managers
- Consultants
CPD Certified
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
