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ISPE Volunteer Week Spotlight: Professional Development Volunteers

ISPE
ISPE Volunteer week

COVID-19 pandemic has caused unprecedented change and disruption to each of our daily lives. All of us around the world are touched by the current pandemic, whether it be personal hardship or professional life challenges. We have seen our communities and our industry rally to work together for the good of public health and humanity. Our ISPE family is no different; several of our local Affiliates and Chapters have led efforts within their community or country to support responses to the impact of COVID-19.

Our network of Members and volunteers is being leveraged for tremendous positive impact in many places around the world. ISPE is celebrating our volunteers from 27 April - 1 May during ISPE Volunteer Week. Each day we will be spotlighting a group of ISPE volunteers highlighting the ways they are getting involved at ISPE to make an impact with the pharmaceutical and biopharmaceutical industry.


Volunteer Role: Member of numerous education program committees, regulatory affairs steering groups, and publication review teams

George has been an active member of ISPE since 1997, as a consistent and contributing member of numerous education program committees, regulatory affairs steering groups, and publication review teams.  He has shared his expertise throughout the years on numerous conference program planning teams, including the Global Pharmaceutical Regulatory Summit, Annual Meeting, and several years leading the Quality Manufacturing program.  George’s positive energy and commitment as a volunteer to ISPE has influenced successful outcomes for every team to which he has unselfishly dedicated his time. He is a kind and valuable mentor to ISPE young professionals entering the industry in support of ISPE’s efforts to impact the development of the workforce of the future. George’s wealth of knowledge has made a significant contribution to the development of ISPE’s global regulatory relationships and initiatives.


Joerg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.

Volunteer Role: ISPE Training Instructor for In-Person and E-Learning Training

Jean-Francois Duliere
Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate

Volunteer Role:  ISPE Regulatory Advisor and Training Instructor

These ISPE instructors go above and beyond by investing time and energy to have a positive impact on the training delivered through ISPE to industry. They have such a wealth of knowledge of best practices, which they are always willing to share. Both Jorg and Jean Francois have been working with ISPE to develop a new e-learning course on Aseptic Processing that will be piloted this year, and which will complement the new Aseptic Training course scheduled in September in Strasbourg, France. 


Biopharmaceutical Manufacturing Planning Committee

Joseph C. Famulare
Vice President, Global Quality Compliance and External Relations
Genentech, A Member of the Roche Group
Chair
Vivianne J. Arencibia
Independent Consultant
Arencibia Quality Compliance Associates
Board Ambassador
Antonio R. Moreira, PhD
Vice Provost, Academic Affairs
University of Maryland, Baltimore County
Andre L. Walker, CPIP
Principal
Walker BioPharm Consulting
Stephen C. Mahoney, JD
Senior Director, Global Quality & Compliance
Genentech, A Member of the Roche Group
Christine M. V. Moore, PhD
Global Head and Executive Director, GRACS CMC Policy
Merck & Co, Inc.
David Doleski
Compliance Head for Biologics Quality Operations
Sanofi
Robert Dream, PE, CPIP
Principal
HDR Company LLC
Eric D. Felz
Associate Director Validation
Takeda Pharmaceutical Company Limited

CoViD-19 has affected all our lives, families, and communities.  When ISPE announced the decision to maintain the June dates for the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference – and transition to the program to a virtual platform – the 2020 Planning Committee jumped right back in!  These 10 volunteer members, whose ‘day jobs’ were already ramped-up due to the virus, forged ahead with reaching out for speakers, writing blogs and other marketing pieces, tapping into their extensive network of industry and regulatory professionals to develop a robust, timely, and interesting program for the biopharma community.

These circumstances have certainly been challenging, but the 2020 Biopharmaceutical Manufacturing program will continue to provide top-level expert knowledge and information to the biopharma community...and now available to attendees anywhere in the world!  Thank you for your expertise, patience, and continuing efforts to make this inaugural ISPE Virtual Conference a great success.  Your contributions to this program and many other ISPE teams are greatly appreciated!

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