Diapharm’s Dr Guido Middeler will explain the regulatory requirements for combination products, consisting of medical devices and medicinal products, during the APV „Drug-Device Combinations“ workshop in Dortmund, Germany. The workshop addresses regulatory and technological challenges of drug-device combinations and related primary packaging components both for Europe and North America. It will cover practical examples for different routes of administration and manufacturing technologies
Programme Part 1: Drug-device combinations: Definitions and regulatory requirements
- Regulatory requirements for Drug Device Combinations (Dr. Guido Middeler, Diapharm)
- Integration of Design Control acc. to ISO 13485 and 21 CFR 820 in device development of new products and life cycle management of existing products (Dr. Felix Weiland, Boehringer Ingelheim microParts)
- Inhalation Devices and perspectives on respiratory development (Dr. Marc Rohrschneider, Boehringer Ingelheim)
Programme Part 2: Drug-Device combinations for different routes of administration
- Disposable inhalers: recent advancements in pulmonary drug delivery (Dr. Anne de Boer, University of Groningen)
- Drug-device combinations for nasal drug delivery (n.n., Nemera)
- Drug-device combinations for ophthalmic preparations (Dr. Matthias Birkhof, Aptar)
- Drug-device combinations for parenteral use (n.n.)
- Electronic oral drug delivery: current status and future challenges (Jeff Shimizu, Medimetrics)
Programme Part 3: Manufacturing Technologies
- Injection Moulding and 3D printing: Recent achievements and challenges (Jürgen Bertling, Fraunhofer Institut)
- RTF-Syringes as key component of injection devices: Insights in key characteristics at the triangle of aseptic pharmaceutical filling, glass manufacturing of sterile packaging components and final combination to the injection device (Claudia Petersen, Gerresheimer)
- Introduction to Boehringer Ingelheim microParts: Technological challenges during upscaling of medical device manufacturing sites (Thomas Mehlhorn, Boehringer Ingelheim microParts)
The two-day programme concludes with a facility tour at Boehringer Ingelheim microParts GmbH, Dortmund (subject to availability/approval). The workshop is organized by APV’s MedTech Task Force. It is designed for professionals working in the pharmaceutical and medical device industry who are actively engaged with the development, manufacture and quality control of drug-device combination products.
Contact:
Diapharm GmbH & Co. KG
Dr. Guido Middeler
Phone: +49 (0)251 60935-0
E-Mail
