Regulatory Requirements regarding Medicinal Products / Drugs
- European Directive about GMP
- EU GMP Guide
- Guide to Inspections of/ Guidances for Industry
- Office of Combination Products
- Marketing Authorisation
- Regulatory Supervision
Regulatory Requirements regarding Medical Devices in the USA
- 21 CFR 800ff
- Guide to Inspections of/ Guidances for Industry
- Classification EU vs USA
- Marketing Authorisation in the USA
Classification of Medical Devices in the USA
- How to classify Medical Devices in the USA
- Examples
How to launch a Combination Product on the market?
- “Combination product”- 21CFR 3.2 e in the US versus “combination products” in the EU
- What do medical device companies need to know about medicinal products?
- What does the pharmaceutical industry need to know about medical devices
- The importance of the primary mode of action (US) and the intended use (Europe)
QM System for Combination Products
- Quality Management System for Drugs
- Quality Management System for Medical Devices
- Similarities and differences
- Qualifying of Suppliers
- Quality Management System for the combination of Medicinal Products with a Medical Device
Workshop on Primary Packaging Material vs. Medical Devices
Case Studies: Approval Process for Combination Products in the EU
- Case Study for a single entity “combination” product – a medical device containing a drug substance having an ancillary action
- Case Study for an investigational medicinal product to be combined with a CE marked medical device (nebulizer)
- Case Study – drug eluting stents – requirements regarding the in vitro- in vivo correlation of the sustained release drug substance in carrier
Human Factor Studies
Crossmatrix EU/USA
- Comparision of EU/FDA Requirements
3 Parallel Workshops
Application of Quality Risk Management to Combination Products
You discuss in the workshop risk management aspects regarding the medicinal product and medical device.
Approval of Combination Products in the EU
The workshop is intended to lay down the basis for a strategy for a „combination product“ taking into account the fact, that in the EU the regulatory frames of medical devices, medical devices containing a drug substance having an ancillary action and medicinal products and the respective quality management systems have to be taken into consideration.
Two cases will be studied:
- A medicinal product having a marketing authorization shall be combined with a medical device in development. How can this be accomplished? What needs to be done, where are possible pitfalls?
- A medical device marked with a CE shall be combined with a medicinal product that is authorized for marketing. What needs to be done, where are possible pitfalls?
Notified Body requirements on Combination Products
The workshop is intended to assess examples of Notified Body audit findings and how to react.