Webinar Series: <br data-src=

Webinar Series:
Navigating EU Product Launch Milestones

Webinar Series: <br data-src=

Webinar Series:
Navigating EU Product Launch Milestones

 
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The speakers in this webinar series are experts in navigating market requirements and supporting client partners to successfully launch their orphan drug products into Europe. They have extensive practical experience in the areas of regulatory, quality, packaging design and distribution of launching products into the various EU and ROW markets, ensuring launch milestones are met and market entry strategy is successful.

During these interactive webinars, our experts will utilise their experience to help you navigate key product launch milestones from submitting your Marketing Application (MA) to final distribution of drug product to the end-user.

Below are details of the webinar series.

Tues 16th June, 3pm BST – EU regulatory submission timeline

Throughout this webinar Brian will share his knowledge and experience of various EU regulatory filing options focusing primarily on the centralised procedure. Brian will highlight the criteria an applicant must meet, highlight the key information required for submission and identify critical time points throughout the centralised procedure process. This webinar will help you navigate the various EU regulatory filing options to allow you to plan ahead and save time in what can be a lengthy and complicated process.

Speaker: Brian Lavery, Regulatory Affairs Lead

Thurs 18th June, 3pm BST – Key QA milestones during product launch

During this webinar, Curtis will outline the key quality milestones to support a successful product launch. From the initial milestone of appointing a Qualified Person (QP) and preparing your QP declaration through to auditing sites in your supply chain, release testing requirements and finally, upon MA approval, QP certification and product launch.

Speaker: Curtis Campbell, Qualified Person

Tues 23rd June, 3pm BST – Key packaging design & operational considerations for product launch

During this webinar Stuart and Robert will share their knowledge and industry experience examining key packaging considerations both from a packaging design and operational perspective. Our experts will help you navigate the multiple EU packaging design requirements to help you ensure your pack format, design and artwork not only meet the needs of your patient and target market(s) but are also processable for your validation and commercial batch operations, helping save time and money when it comes to commercial launch.

Speakers:  Stuart Hunter, Packaging Design Manager and Robert O’Brien, Head of Technical Support, Packaging

Thurs 25th June, 3pm BST – Product launch supply chain milestones & post-Brexit considerations

This webinar will provide an overview of key supply chain milestones and post-Brexit considerations for planning your EU supply chain strategy.  Emma Jordan, Logistics Manager, will apply her wealth of experience and highlight some of the practical considerations of setting up your supply chain to get your drug to market.  From examining finance and customs, the various supply chain models and even the regulations that govern your supply chain.

Reviewing one of the latest post-Brexit regulations the ‘Northern Ireland Protocol’, Ivan Waide, Head of Patents & Licensing, Almac Group will provide insight into the Protocol and its impact on the supply chain and movement of pharmaceutical drug products within Northern Ireland, the UK and the European Union.

These key supply chain and regulatory insights will ensure you are adequately prepared for a successful product launch upon MA approval.

Speaker: Emma Jordan, Logistics Manager and Ivan Waide, Head of Patents & Licensing

Speakers

Brian Lavery

Regulatory Affairs Lead
Education: MPharm Pharmacy

Brian has worked in the Scientific Affairs Department of Almac Group for the past fifteen years. His experience encompasses development, pre-approval and post-approval regulatory activities in both the EU and US. This includes the management of scientific advice meetings, compilation and submission of clinical trial applications, and the management, compilation and submission of new Marketing Authorisation applications for medicinal products in the EU. Brian has provided regulatory support to a number of Almac Pharma Services clients in recent years who have made successful EU regulatory filings via the centralised procedure. Brian also has experience with the maintenance of INDs and NDAs for US drug products.

After graduating from Queen’s University Belfast with a Master’s degree in Pharmacy, Brian completed his training as a Pharmacist with Alliance Pharmacy subsequently working as a Pharmacist Manager for the company for one year prior to joining Almac.

Curtis Campbell

Qualified Person
Education: BSc Biomedical Sciences; MSc Pharmaceutical Manufacturing Technology

Curtis has worked at Almac Pharma Services for the past 9 years developing his pharmaceutical experience in the QC analytical laboratory prior to moving to the product quality function of the Quality Assurance department where he played a role in the EU launch and continuous quality management of various products including Solid Oral Dosage forms, Powders, Biologics and Sterile Small Volume Liquids.

Curtis expanded on his product quality experience from his time seconded to the project team responsible for the establishment of Almac Pharma Services new pharmaceutical development and commercial manufacturing facility in Loughborough, UK. His experience branches the commissioning and qualification of the facilities, utilities, equipment, computerised systems, the implementation of a pharmaceutical quality system and the successful granting of the sites Manufacturers Importers Authorisation.

Curtis is a QP named on both the Craigavon, UK and Dundalk, Ireland MIAs where he is responsible for batch certification of various products classifications in accordance with their manufacturing authorisation. In his role, Curtis continues to advise clients to ensure their products meet current EU requirements for a launch and throughout their product lifecycle.

Stuart Hunter

Packaging Design Manager
Education: City & Guilds of London Diploma in Lithographic Printing; City and Guilds of London Diploma in Artwork & Design for Print

Joining Almac Group in February 2010 as Packaging Design Manager, Stuart has almost 20 years of pharmaceutical packaging and artwork experience in which he has assisted in the launch of various product globally.

Stuart has significant experience working with regulatory affairs, supply chain and operation for the strategy and implementation of medicinal products in global markets including Europe, USA, Canada, Japan, Australia, New Zealand, Brazil and South Africa / other African markets.

While responsible for the packaging design, artwork creation and management of all printed commercial packaging components, Stuart also possesses extensive printing knowledge across all platforms and acts as the primary interface with print packaging suppliers to ensure components are printed and manufactured as per design specification.

Robert O’Brien

Head of Technical Support, Packaging
Education: BSc Chemistry; Diploma Packaging Development Technology

Robert has almost 20 years’ experience in managing commercial product launches in both pharmaceutical and FMCG industries. Over this period, he has led multi-disciplinary teams to support a number of challenging, but ultimately, successful, global product launches and transition into on-going commercial supply. Leading the Technical Support function within Almac Commercial Packaging, he and his team are responsible for end-to-end operational launch. From product & process design, through validation requirements to timely commercial production and launch.After graduating from University of Liverpool, Robert spent the majority of his career in the soft drink industry working for both Coca-Cola and Britvic plc on national and international developments and product launches, before transferring to pharmaceuticals.

Emma Jordan

Logistics Manager
Education: BSc Economics with Finance

Emma is responsible for the Logistics function within Almac Pharma Services; encompassing the distribution, warehousing and procurements functions of the business. The Logistics department is responsible for processing customer sales orders, managing the despatch of temperature controlled material throughout Europe and Rest of World, as well as managing procurement on a global scale.

The recent expansion of Pharma Services’ client service offerings means that Emma is responsible for the development of the 3PL, cold chain despatch and Supply chain Qualification processes for the company.

Emma joined Almac Pharma Services after graduating from University and had held different roles within the Logistics Department of the company. She has gained significant experience in several fields within Logistics where she has been responsible for negotiating contracts with suppliers and working with clients to help develop bespoke supply chain solutions for their products.

Emma is listed as Responsible Person on the Almac Pharma Services Wholesale Distribution Authorisation (WDA).

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