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Tuesday, June 18 • 1:15pm - 2:15pm
#255: International Harmonization to Support Pharmaceutical Quality and Lifecycle Management

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-594-L04-P; CME 1.00; RN 1.00

Since establishment in 1990, the International Council for Harmonisation (ICH) has expanded its global footprint to harmonize requirements for the development of medicines and to increase patient access to medicines. Importantly, ICH’s quality portfolio serves to support continual improvement and innovation in biopharmaceutical manufacturing. In 2018, ICH published its quality mission to “develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science” driving the development of several new guidelines addressing topics on lifecycle management, quality risk management, continuous manufacturing, and analytical procedure development and validation. With ICH’s expansion, it has prioritized the adequate implementation and adherence of guidelines through its work to promote training and periodically conduct a survey to assess guideline implementation by ICH Members and Observers. This session will provide global regulatory and industry perspective regarding progress made on the ICH quality mission and explore future opportunities to achieve greater harmonization and encourage the global community to embrace the science and risk-based approaches. Case studies will be presented highlighting the objectives and work to facilitate a globally aligned approach to implementation of ICH guidelines.

Learning Objectives

Describe objectives of international harmonization through ICH to promote innovation and facilitate more efficient lifecycle and post-approval change management; Discuss status of key ICH Guidelines such as Q13, Q12 and Q14 and their implementation globally; Evaluate case studies and identify opportunities to advance global harmonization.

Chair

Amanda Marie Roache, MS

Speaker

Lifecycle Strategies at the Interface Between ICH Q12 and ICH Q14
Connie Langer, MSc

ICH Q14: Analytical Procedure Development and Lifecycle Management
Nina S. Cauchon, PhD

FDA Update
Sau L Lee, PhD

Update from Japan on Q12
Satomi Yagi


Speakers
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →
avatar for Nina Cauchon

Nina Cauchon

Director Regulatory Affairs CMC, Amgen, United States
Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies... Read More →
avatar for Connie Langer

Connie Langer

Senior Director, Pfizer Inc, United States
Connie Langer is a Senior Director at Pfizer who leads a team that monitors and advises on regulatory changes and impacts. She collaborates with experts to communicate Pfizer's feedback and position to health authorities on regulations and guidance documents. She also has experience... Read More →
SY

Satomi Yagi

Reviewer, Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA)
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
avatar for Sau Lee

Sau Lee

Deputy Super Office Director, OPQ, CDER, FDA, United States
Dr. Lee is currently Deputy Super Office Director for Operations who oversees research, quality surveillance, policy, quality assurance, and administrative operation functions in CDER’s Office of Pharmaceutical Quality. Dr. Lee has been with the FDA since 2005, serving as a regulatory... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum |   10: RegCMC-Product Quality, Forum
  • Format Forum
  • Level Intermediate
  • Featured Topics ICH
  • Level Intermediate
  • Feature Topics ICH
  • Credit Type ACPE, CME, RN
  • Tags Forum