ISPE Announces Senior Industry Executives and Global Regulators to Open 2021 ISPE Annual Meeting & Expo


The International Society for Pharmaceutical Engineering (ISPE) announced the addition of four new keynote presenters for the 2021 ISPE Annual Meeting & Expo. Taking place 31 October–3 November 2021 in Boston, Massachusetts, this signature event brings together top pharmaceutical industry and regulatory leaders offering compelling and enlightening presentations and interactive discussions on industry-critical technical developments.

The 2021 ISPE Annual Meeting & Expo features a dynamic line-up of thought-provoking keynote presentations led by some of the most prominent names in the pharmaceutical industry.

Confirmed Keynote Presenters:

Elizabeth Miller, Pharm.D, Assistant Commissioner for Medical Products and Tobacco Operations, FDA/ORA

Session title: Regulatory Resiliency in Challenging Times

Dr. Elizabeth Miller recently rejoined the US FDA in March 2020. In her role as the Assistant Commissioner for Medical Products and Tobacco Operations, Dr. Miller provides leadership and managerial direction to ORA’s Office of Biologics Products Operations, Office of Pharmaceutical Quality Operations, Office of Medical Device and Radiological Health Operations, Office of Bioresearch Monitoring Operations, and the Tobacco Operations Staff.

Robin Kumoluyi, VP & Chief Quality Officer, Janssen Pharmaceuticals

Session title: Leading with Agility: How the COVID-19 Pandemic was a catalyst for new collaboration and innovation at Johnson & Johnson

Robin Kumoluyi is the Vice President and Chief Quality Officer, Pharmaceuticals at Johnson & Johnson Corporation. Robin has responsibility for Quality & Compliance for the Global Pharmaceuticals Segment in Pre-Market R&D, Supply Chain and Post Market Commercial. Her proven track record spans thirty years of robust experience leading change while holding senior leadership roles within Quality, R&D, and Manufacturing Compliance in the pharmaceutical and food industries.

Rajiv Malik, President, Viatris

Session title: Building a New Healthcare Company: Meeting the World’s Evolving Needs Through Access, Leadership and Partnership

Rajiv Malik is president of Viatris and a member of the company’s board of directors. He has more than 36 years of experience in the pharmaceutical industry. He is responsible for the day-to-day operations of Viatris, overseeing the company’s commercial business units, the Commercial Development, Medical, IT and Quality functions, as well as R&D and Operations. Malik’s unique leadership profile combines scientific, operational and commercial expertise, strong financial acumen and a global perspective on healthcare challenges.

Deusdedit Mubangizi, Unit Head Prequalification Unit (PQT) Regulation & Prequalification Department, World Health Organization

Mr. Mubangizi is a senior regulator with experience in the regulation of pharmaceutical products, Vaccines, Vector Control Products and In-Vitro Diagnostics. He is currently the Unit Head of the Prequalification Unit (PQT) within the Regulation and Prequalification Department (RPQ) of the World Health Organization (WHO), based in Geneva, Switzerland.

To learn more about this event and to register, visit http://www.ISPE.org/AM21.

About ISPE

The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000+ Members of ISPE provide solutions to complex pharmaceutical industry challenges through innovation, member and workforce development, technical, regulatory and compliance collaborations in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.

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