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Sustainability and CMC (Chemistry, Manufacturing and Controls)
Session Chair(s)
Kirsty Reid, PhD, MSc
Director Science Policy
EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium
The session will focus on the impact of the Green Deal initiative as priority of the EU which will have an impact on the healthcare sector, particularly on the continuity of pharma R&D and manufacturing. The session will bring together those who are engaging in developing relevant EU chemical and environment legislative and non-legislative dossiers (Commission, regulators), and those who will be impacted (industry, suppliers) to discuss three identified case studies and discuss opportunities. This track will provide insights into how manufacturers and regulators can collaborate to deliver this revolution without risks to the supply of medicines. Participants will be invited to share their concerns and ideas to progress innovation and concepts in moving towards a more sustainable future of the healthcare sector.
Learning Objective : Identify case study areas of expected heavy impact where stakeholders from industry, SMEs, regulators will come together to share concerns and discuss opportunities and solutions on how to manage a more sustainable and environmentally positive future
Speaker(s)
Matt Popkin, PhD
GSK, United Kingdom
Senior Director, CMC Excellence, Global Regulatory Affairs
Building a regulatory framework to support innovation to medicines supply to meet patient access and environmental targets
Mónica Perea-Vélez, PhD, MSc
GSK, Belgium
CMC Advocacy and Policy Director
Case study: Packaging Materials and Primary Containers
Bert Verstappen, MS
Johnson & Johnson, Belgium
Manager Environmental Sustainability Belgium
Environment and Sustainability Goals of the European Pharmacopoeia
Cathie Vielle, PharmD
EDQM/Council of Europe, France
Head of the European Pharmacopoeia Department
Sustainability in Medicines Development & Manufacturing – an EMA Perspective
Veronika Jekerle, PhD, RPh
European Medicines Agency, Netherlands
Head of Pharmaceutical Quality
Panelist
Carmen Laplaza-Santos
European Commission DG SANTE, Belgium
Head of Unit of Health Innovations & Ecosystems
Panelist
Helerin Eiche
State Agency of Medicines, Estonia, Estonia
Quality Assessor
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