Key EU Regulatory Licensing Requirements

November 23, 2022. 10:00AM EST/ 3.00PM IST

Orphan Drug Consulting is hosting a series of Quality Assurance webinars for the month of November. Our second webinar of the series will feature Kevin Lyons, Senior Quality Assurance Manager, and Sharon Cullen, Head of Quality from Orphan Drug Consulting.

Join Kevin Lyons and Sharon Cullen as they present ‘Key EU Regulatory Licensing Requirements.’ Some of the main European licenses needed to distribute medicinal products in the EU are the Marketing Authorisation (MA), Manufacturer Importers Authorisation (MIA), and Wholesaler Distribution Authorisation (WDA). This webinar looks at the main components of the MIA and WDA licenses and how they relate to your European entity, while our final webinar of the series goes into more detail on the MA and the responsibilities an MA Holder (MAH) has to comply with. The Orphan Drug Consulting team brings the best of industry experience to obtaining, implementing, and maintaining these European licenses for your company to ensure a safe and compliant supply of products.

In the 15-minute webinar, the team gives an overview of setting up your European entity and the key European licenses and release requirements needed to distribute medicinal products in the EU.

Kevin has over 15 years of experience working in the pharmaceutical industry through his role as a registered pharmacist. As Senior Quality Assurance Manager, Kevin brings a unique insight arising from his time working in patient-facing roles as well as his experience and training in GDP and GMP. He has experience throughout the product supply chain from working with product owners right through to end-users. Kevin is eligible to act as a Responsible Person/Deputy Responsible Person on behalf of clients.

Sharon Cullen is Head of Quality for Orphan Drug Consulting, she has extensive experience in senior leadership roles in the Life Science industry with a focus on the Pharmaceutical Quality System (PQS) including auditing, regulatory inspections, lean and continuous improvement, compliance, quality excellence, training, management review, CMO oversight, quality data integrity, analytics and enabling technologies, affiliate quality oversight, and global quality operations including QP responsibilities, QC laboratory, and packaging.

About Orphan Drug Consulting Ltd
Orphan Drug Consulting coordinates product launches into the US, EU, and other international markets providing strategic support in the areas of supply chain, quality assurance, vendor management, and entity management with its team of experienced industry professionals. From full-service solutions to solving specific immediate requirements, Orphan Drug Consulting is your partner of choice to manage market complexities ensuring your successful product launch to meet your patients’ needs.

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