Seminar on primary packaging for medicine and medical devices

Polymer materials are essential components in packaging materials for medicine and in medical devices. They are flexible, cheap and versatile materials with a high chemical and physical stability, and many polymer materials are well characterised for medical purposes.

However, there is an increasing awareness that polymer materials may contain leachable substances, including additives, plasticizers, residual monomers or other substances which may be potentially harmful.  Consequently, both industry and regulators have an increased focus on leachable substances from materials used in medical devices and in primary packaging for medicine.

At this seminar we focus on efficient ways to approach the challenge of characterising and evaluating the safety of potentially leachable substances. You will get insight into the regulatory requirements and scientific options to identify, assess and document the safe use of polymer materials.

Tentative programme

• regulatory requirements for evaluation of leachable and extractable substances according to ISO 10993 and guidelines from EMA
• how to identify leachable and extractable substances from polymer materials; the challenge of chemical analysis for identification of possible “unknown” chemicals 
• how to perform a toxicological safety assessment of leachable or extractable substances 
• use of QSAR in the safety assessment of leachable and extractable substances 
• endocrine disruptors – a special group of harmful leachable substances 
• nanomaterials – a new group of materials in relation to medical devices and pharmaceutical packaging.

Target group
Professionals working with the development, manufacturing, registration or marketing of medical devices or pharmaceuticals, who are interested in the regulatory requirements for the use and safety documentation of polymer materials.

Chair
Brian S. Nielsen, MSc.

Date and venue
Copenhagen area
Final date still pending

Price
DKK 550 excl. of VAT.

Registration
Vibeke Salmon
Tel  +45 4516 9144
ves@dhigroup.com