More than 500 participants attended ISPE’s 2017 Europe Annual Conference in Barcelona, Spain. The combination of very strong and relevant topics, quality speakers, venue, and Young Professional activities contributed to engaging standing room only sessions.
Mike Rutherford presented on Data Integrity and David Churchward, Expert Inspector from MHRA presented the Clinical and ATMP Supply Chain on “What is Innovation to Authorities". Gert Moelgaard engages with some of the Young Professionals in attendance and Director Vladislav Shestakov and members of his staff from the Russian Delegation pose with ISPE leaders. You could feel the energy and hear the buzz from the participating sponsors, vendors, and members. Well done everyone! I look forward to attending the 2018 Europe Annual Conference!
Other Newsworthy Updates The Global Regulatory Compliance Committee (GRCC) continues their efforts to further define and clarify objectives, roles, and responsibilities of this committee. Several of the committee leaders met with the EMEA RCC sub-committee to share thoughts and considerations. The discussions were fruitful and moved us closer to finalizing the path forward. Watch for future communications on this. ISPE CEO and several International Board Members met with the European Affiliates Council (EAC). We met to share thoughts on the importance of our members and volunteers and how we might all work more effectively together. It was a great opportunity to share our collective thoughts and it was clear to me that everyone shares a common vision which is to ensure ISPE is successful, members see tangible benefits, and our volunteers feel supported. To all who participated, thanks for your “transparency” and support of ISPE. The International Board of Directors met while in Barcelona. We acknowledged the successful web-based training of Turkish Regulators. Thanks to Fatma Taman for coordinating the event with the Regulators and Tony Moreira for leading the training effort. Our budget is on track and conferences are performing well. In an effort to ensure sustained support of ISPE staff and our volunteers, the Board approved a proposal to hire three new “operations” positions. Cheers to all from Barcelona!
Senior Director, Strategic Partnerships & Past ISPE Board Chair
Pfizer Global Clinical Supplies
Michael A. Arnold is Senior Director of Strategic Partnerships and Investigational Products Business Process Owner for Pfizer's Global Clinical Supply Chain. In this capacity he...
Are you considering joining ISPE? Or maybe you’ve recently joined the society or are a longtime member looking to better understand all the benefits available to you. If so, you’ve come to the right place!
ATMPs are based on genes, cells or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest. Often referred to as ‘Personalised Medicine’. A sector of healthcare that is rapidly evolving and expanding with some unique challenges such as microbial contamination and product variability. Traditional manufacturing processes are for synthetically derived...
GAMP® 5 Second Edition is here! Since its publication, GAMP® 5 has been far and away the leading international guidance on GxP computerized systems validation and compliance, and it was time to update our guidance to...