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Wednesday, June 19 • 10:00am - 11:00am
#327: Enabling Innovation and Regulatory Agility to Address Sustainability, Environment, and Climate Goals

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-645-L04-P; CME 1.00; RN 1.00

This session will include the regulator and industry perspective on the Green Deal initiative and chemical agenda and will have discussions on identified case study areas of expected heavy impact where panelists from industry, SMEs, and regulators will come together to share concerns and discuss opportunities and solutions on how to manage a more sustainable and environmentally future – for example through regulatory tools which enable innovation to address the challenges.

Learning Objectives

Identify insights into how manufacturers and regulators can collaborate to deliver a revolution without risks to the supply of medicines.

Chair

Ana Padua, MSc, RPh

Speaker

EMA Update
Veronika Jekerle, PhD, RPh

Sustainability and CMC (Chemistry, Manufacturing and Controls)
Benjamin Stevens, PhD, MPH


Speakers
avatar for Ana Padua

Ana Padua

Director EU Global Regulatory and Scientific Policy, EMD Serono, Switzerland
Ana has over 19 years of pharmaceutical industry experience starting in Analytical Development (2-year) and then Regulatory Affairs area by working for Medley (Brazil), Novartis (Brazil and Switzerland), Parexel (Brazil) and in the last 8+ years for Roche leading the CMC Regulatory... Read More →
avatar for Veronika Jekerle

Veronika Jekerle

Head of Pharmaceutical Quality, European Medicines Agency, Netherlands
Veronika Jekerle hold the position as Head of Office for EMA’s Pharmaceutical Quality Office in the Human medicines Division at European Medicines Agency. The office manages pharmaceutical quality aspects for all human medicines across the lifecycle from early development to post-authorisation... Read More →
avatar for Benjamin Stevens

Benjamin Stevens

Director CMC Policy and Advocacy, GlaxoSmithKline, United States
Ben Stevens is a Director of CMC Policy and Advocacy at GlaxoSmithKline and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam, a Principal Consultant at PAREXEL and an acting Branch Chief in the Office... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session