Catalent will also Discuss Direct-to-Patient Clinical Supplies, the Impact of Brexit on VAT Handling, and Japan’s Cultural and Regulatory Environment
SOMERSET, N.J. – April 18, 2019 — Catalent, a global leader in clinical supply services, today announced a number of workshop presentations at the upcoming Global Clinical Supplies Group (GCSG) 2019 US Annual Conference at the Hyatt Regency Hill Country Resort & Spa, San Antonio, Texas, on April 28 – May 1, 2019.
Erin Vlack, Project Manager, will present a workshop titled “ Bridging the Cultural and Regulatory Gaps in Japan. ” The workshop will discuss Japan’s regulatory requirements for packaging, labeling, and distribution of clinical supplies, and how they impact clinical trial timelines and planning.
A workshop entitled “ Maintaining a Patient-First Perspective in Your Clinical Supply Chain, ” which will discuss techniques to improve site operations using a patient-centric approach will be hosted by Eric Valentine, Vice President, Clinical Supply Services.
Additionally, Nicole Gray, Director, Strategic Supply Solutions will co-present the “ Direct-to-Patient ” workshop that will discuss the use of central pharmacies in a direct-to-patient supply chain model.
Also at the conference, Paul Ingram, Ph.D., Global Director, Strategic Development and Innovation, Clinical Supply Services, will present “ Brexit’s Impact on Valued Added Tax (VAT) Reclamation, ” discussing how Brexit may change the ability of clinical sponsors to reclaim VAT within the U.K. and European Union (EU) for clinical supplies, both during transition and post-implementation. Dr. Ingram will also co-present a session titled “ Annex 13 and Annex VI Requirement Changes ”, which will discuss the changes that have been made in anticipation of the implementation of the new EU Regulation 536/2014, and how they impact clinical supplies.
Ms. Vlack has over 25 years’ experience in the Japanese market, and has extensive expertise in the design and strategy of Japanese clinical supplies and on advising foreign companies wishing to do business in Japan.
Mr. Valentine has more than 20 years’ experience in leadership positions in clinical research and drug development organizations. In his current role at Catalent he is responsible for client services, depot network services, transportation services, comparator services and strategic projects.
Ms. Gray has 15 years’ experience in the pharmaceutical industry across multiple roles in clinical supplies management. In her current role at Catalent, she is responsible for leading the Direct-to-Patient business and other new strategic service offerings.
Dr. Ingram’s 25-year career has focused on medical device and pharmaceutical research and development. He obtained his doctorate in pharmaceutical development from Strathclyde University, Scotland, and has over 15 years of experience in clinical supplies, working both in Phase 1 units and trial supply service companies including Quintiles (Aptuit), Fisher Clinical Services and, since 2011, at Catalent.
For more information visit www.catalent.com/index.php/news-events .
To arrange a meeting with Catalent at the conference, contact Richard Kerns at NEPR - email@example.com .
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Catalent is the leading global diversified provider of advanced delivery technologies drugs, biologics, and consumer health. With more than 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal year 2018 generated approximately $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com .