Connie Langer
Director, CMC - Global Regulatory, Pfizer
Connie Langer is a chemical engineer and director at Pfizer Global Product Development in Groton, CT. She has 24 years of increasing responsibility in the pharmaceutical industry including extensive experience implementing science- and risk-based approaches in support of innovative products. She is currently accountable to recommend strategic regulatory options to achieve product approvals globally. Connie is a member of Pfizer’s Dissolution Advisory Council, chair of the International Consortium for Innovation and Quality in Pharmaceutical Development ICH Q12 working group and a member of the ISPE PQLI® ICH Q12 Working Team and the ISPE RQHC Modernization of Module 3 Working Team as well as a member of the PhRMA ICH M4Q Limited Duration Team.
Appearances
DateNovember 1, 2022The pace of innovation in the pharmaceutical field is accelerating and the development of a global, flexible and harmonized regulatory framework will be a key enabler to bring medicines to patients faster…Session Leader
Senior Director and Group Manager, Project and Product Leadership, AstraZenecaSpeakers
Global CMC Senior Manager - PTx At Pfizer, PfizerVP, Product and Process Development, Pharmatech AssociatesDirector, CMC - Global Regulatory, Pfizer
DateNovember 2, 2022The pandemic has brought about an expectation of increased speed to deliver new medicines to patients, while the boundaries of science are being extended to deliver life-changing drugs to treat, prevent, modify, and even cure diseases…Session Leaders
Operations Lead and Start-up Manager, AstraZenecaSenior Director and Group Manager, Project and Product Leadership, AstraZenecaDirector, CMC - Global Regulatory, PfizerSpeakers
Sau (Larry) Lee, PhDDeputy Director of Science Chair, Emerging Technology Program, Office of Pharmaceutical Quality/CDER/FDAPeter Marks, MD, PhDDirector, Center for Biologics Evaluation and Research, CBER/FDAHugo Hamel, MSc, MBAManager, Biotherapeutic Quality Division, Health CanadaHead of Department of Pharmaceutical Assessment, State Institute for Drug ControlHead of Operations Quality Compliance and External Affairs, AstraZenecaManager of National QC Laboratories Dept (GELAS/Anvisa), National Health Surveillance Agency - ANVISADeputy Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA)Lead Scientific Officer, EMA
DateNovember 1, 2022Concurrent Session: Regulatory Considerations to Boost Innovation and Supply Chain Resilience | The pace of innovation in the pharmaceutical field is accelerating and the development of a global, flexible and harmonized regulatory framework will be a key enabler to bring medicines to patients faste…Speakers
Director, CMC - Global Regulatory, PfizerAdam Lambert, PhDVP, Product and Process Development, Pharmatech AssociatesGlobal CMC Senior Manager - PTx At Pfizer, Pfizer
DateOctober 17, 2023ICH delivers guidance on science- and risk-based strategies and is an enabler of greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner…Session Leader
Director, CMC - Global Regulatory, PfizerSpeakers
Director of CMC Policy & Advocacy, GlaxoSmithKlineSite Quality Head: Clinical & Commercial Cell Therapy Operations, AstraZenecaExecutive Director, CMC Regulatory Affairs, Gilead Sciences, Inc.Mahesh R. Ramanadham, Pharm.D./M.B.A.Deputy Director, FDA/CDER/OPQ/OPPQPrincipal, SynoloStats
