HOT TOPICS Drug/Device Combination Products
Considerations for product development and lifecycle management
- Current and future regulatory framework
- Submission and quality requirements
- Article 117 MDR and its impact on drug-device combination (DDCs) products
- Clinical considerations and vigilance obligations
- Drugs combined with medical apps
Aims and objectivesThe regulatory requirements in the drug- and medical-device sector pose numerous challenges to your products. Especially the new Article 117 MDR and the draft guideline on quality requirements for DDCs will impact the industry regarding regulatory and quality-related issues, among others.
After attending this training course, you will
- be able to classify your product in the correct product group,
- know the consequences of current case law for the development, approval and post-marketing surveillance of your product,
- know the impact of Article 117 MDR and
- discuss the new quality requirement for DDCs.
Day 2: 09:00-16:30
- Definition, differentiation and classification: Medicinal product, medical device, combination product, drugs linked to a medical device
- Case studies for classification
- Advantages and disadvantages of product groups
- Regulatory framework for product groups
- Current legal decisions
16:00 Coffee break
- Consultation and regulatory approval process
- Communication between manufacturers, notified bodies and authorities
- Technical documentation requirements
10:15 Coffee break
- Draft guideline on the quality requirements for DDCs
- Quality requirements for device-drug
- European requirements
- Integral and non-integral products
- Clinical requirements, study design, choice of endpoints
- Integration of quality, pre-clinical and clinical requirements
14:45 Coffee break
- What are the differences?
- What are the similarities?
- QMS requirements
- What will the future bring?
- Data, GDPR and medical apps
16:30 Seminar ends
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Head Medical Device Department; Jan-Bart Hak is heading the medical device department of ProPharma Group, in Leiden, the Netherlands. He and his team provide services, internationally, in various medical device related areas such as quality management systems, regulatory affairs, clinical strategy, vigilance and product development. Prior to ProPharma Group, Jan Bart held different management positions in clinical and regulatory affairs at international oriented companies, such as Xendo, QPS and Cordis (Johnson & Johnson). He also worked at a start-up company in biodegradable medical devices, which is currently a successful company. As a Medical Biologist, Jan Bart holds a Ph.D. degree in cardiac physiology.
Nähere Informationen finden Sie hier.
Professor of pharmaceutical policy and regulatory science and Scientific Director Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation
Senior Consultant Regulatory Affairs He is a pharmacist by education and graduated from Utrecht University in 1997. His main expertise is in the field of Regulatory Affairs and Development (RA&D). In addition he has been acting as qualified person (QP) for pharmaceutical raw materials and clinical QP for biotech products. During his most recent project he was involved in the development, dossier writing and Marketing Authorization Application of a generics dry powder inhalation (DPI) medicinal product with a dedicated inhalation device, where he was part of a team with different experts (nonclinical, clinical, RA, Medical Devices, Pharmacovigilance, Device Vigilance), working closely together with the client and related contract manufacturers.
NL 2332 KG Amsterdam / Leiden
Telefon: +31(0) 71 535 5555
Fax: +31(0) 71 53 55 553
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