Challenges in Drug/Device Combination Products
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.
Over two days, 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.
Suitability - Who should attend?
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
- Project managers
Outcome / Qualification etc.
Challenges In Drug/Device Combination Products
Training Course Content
- Comprehend how combination products are defined and classified
- Understand the regulations for drug/device combination products
- Gain an understanding of the roles of Competent Authorities and Notified Bodies
- Learn about CE marking for separate devices in drug/device combinations
- Compare labelling requirements for medical devices and pharmaceutical products to consider how labelling concerns may be different for combination products
- Examine best practices for working with medical device suppliers and manufacturers
- Consider special requirements for clinical trials for combination products
- Discuss how to integrate a risk management approach
- Understand design control expectations
- Consider Pharmacovigilance requirements
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
85% had applied content during the course to their role
Average rating 5
I already knew a bit about combination products but the device perspective presented here really helped me to see it from a different angle.
The ability of the trainer to explain the topics in a clear manner was great.
It was useful to learn about registration of drug-device as a drug to the EU/US FDA.