EU Product Launch – Key Considerations for Successful Niche and Orphan Drug Product Launches
Presenters: Ian Markwell , Ryta Kuzel , Michael Rooney , Mike Boyson
This FREE webinar was recorded on:
Thursday, February 9, 2012,
12:00 PM - 1:00 PM ET
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Launching your drug product onto the European Market can present a real challenge if you are not familiar with country specific requirements, particularly if you are based in the U.S. With its 27 member states, numerous official working languages and complex regulatory framework, this webinar will clarify the key requirements for a successful EU product launch.
During this interactive webinar, speakers involved will utilise their experience to guide you through the EU product launch process, from submitting your MAA to project management of routine supply.
By participating attendees will gain insight into:
- The European regulatory framework & the various market access strategies
- The importance of the role of a Qualified Person (QP) and market release requirements.
- Key considerations for launching a drug product in Europe
- Millennium: The Takeda Oncology Company Case study: Real-life experiences of a US Pharma company who successfully launched product in Europe
Attendees will also have the opportunity to participate in a live Q&A Session.
This webinar is intended for:
- Company personnel from global pharma / biotech companies involved in the launch of new products into non US territories or regions, specifically the EU.
- Personnel involved in regulatory filing / MAA submission, Outside of USA (OUS) supply chain and distribution.
VP of Quality & Qualified Person
Ian has 22 years experience in all aspects of Quality Control and Quality Assurance for oral, solid dosage forms, powder dosage forms and non-sterile liquids, with experience in QC/QA aspects of formulation and development projects from phase I clinical supplies through to scale-up for commercial operations, as well as the monitoring of commercial operations.
Ian has been involved in the initiation and management of commercial importation projects for a range of sterile and non-sterile pharmaceutical dosage forms. He has advised clients in the EU requirements for QP certification of imported products, and has been an active participant in project teams involved in the launch of commercial imported products onto the EU market.
Ian has led the Almac Pharma Services audit team in EU and US regulatory inspections and routine customer audits. He is named on Almac Pharma Services Manufacturers Importers Authorisation as responsible for Quality Control on site, and has been a Qualified Person responsible for the release of batches to market, for the last twelve years.
Director and Owner
VigiReg Consulting Ltd
Ryta Kuzel has 18 years of European Regulatory Affairs experience with both large multinational Pharma companies as well as smaller Regulatory organisations. She has worked across many therapeutic areas and stages of drug development including submitting and gaining approval of products through the Centralised and Decentralised procedures, as well as heading up Regulatory Intelligence and Training functions and representing industry at various trade associations.
Product Supply Manager
Education:BSC (Hons) Applied Biochemical Science
Michael has over 9 years experience working in the Pharmaceutical industry including 6 years in his current role as Project/Product Supply Manager. In this time he has been responsible for leading multi-disciplinary teams consisting of personnel from QA, QC, Packaging Design, Production and Logistics, in order to support a number of challenging, but ultimately successful product launches/site transfers and on-going commercial supply to global markets, successfully launching numerous high value niche and orphan drug products into the EU for US based clients.
After graduating from University of Ulster with a degree in Applied Biochemical Science, Michael went on to spend 3 years as an Analytical Chemist for a major US Pharmaceutical company, where he gained valuable experience with analytical transfers, validation, stability and EU Import analysis.
Senior Manager, Commercial Quality Assurance
Millennium: The Takeda Oncology Company
Education: Degree in Microbiology from the University of Massachusetts
Mike Boyson is a Quality and Supply Chain professional, specializing in commercial supply for global products at Millennium: The Takeda Oncology Company. Recognizing emerging trends in GDP, identifying greater challenges that more complex products have brought to the business, and leveraging contract manufacturers/logistics firms; Mike and his colleagues have established supply chains, led product launches, and qualified distribution. After graduating from the University of Massachusetts with a degree in Microbiology, Mike went on to work in Quality Control and Quality Assurance roles at companies in the Cambridge area. He has been closely involved in developing and implementing creative techniques for delivering drugs that range in volume from ultra-orphan to product which ship four million vials per year; mostly of the liquid fill or lyophilized parenteral variety. He has experience with cold chain and with multi-national distribution.
As of late, Mike has assumed the management of Commercial Manufacturing, and Production Planning at Millennium.
With over 30 years’ experience, Almac is an FDA and EU approved outsourcing partner to the global pharmaceutical and biotechnology industries. We provide a range of integrated commercial services from manufacturing of drug product, analytical testing, primary and secondary packaging to distribution to the end-user.
Processing solid oral dose and sterile presentations in novel pack formats, we offer a range of packaging solutions to meet client partner needs. With state-of-the-art commercial technology we have the capability of processing small scale, biopharmaceutical niche/orphan drug products for specialist direct to pharmacy distribution up to large scale, routine commercial supply.
Recent commercial packaging developments at Almac:
New US commercial packaging facility: With an investment of $10m, the 100,000ft2 Almac site at Audubon, PA has been reconfigured to provide flexible, quality driven packaging solutions.
Expansion of UK commercial packaging capacity with the acquisition of a state-of-the-art Noack N 623 blister packaging line from Romaco. The acquisition comes in response to growing client demand for enhanced flexibility related to larger blister sizes and innovative multi unit blister formats, coupled to a requirement for non permeability and enhanced environmental protection, particularly product humidity control.
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