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Monday, June 17 • 11:00am - 12:00pm
#112: Regulatory Convergence for CMC Requirements: The Challenges and Benefits of a Single Global Dossier

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-526-L04-P; CME 1.00; RN 1.00

The session will share concrete experiences and expectations for the use of a single global dossier for CMC requirements. The panel will bring perspectives of regulators and industry, connecting the topic to regulatory convergence and reliance.

Learning Objectives

Identify the benefits of a single global dossier strategy for regulatory convergence and reliance initiatives in the area of CMC; Describe experiences from multinational companies with the implementation of harmonized dossier content for global submissions; Analyze and discuss the challenges and opportunities perceived by regulators for the use of a single global dossier for CMC requirements.

Chair

Ana Padua, MSc, RPh

Speaker

ICH M4Q(R2): Opportunity for One Global Dossier
Lawrence Yu, PhD

EMA Update
Evdokia Korakianiti, PhD, MSc

ANVISA Update
Nélio Cézar de Aquino, SR, MSc

Regional Regulatory Hub Strategist Team Lead: Specialty Care Portfolio LatAm
Agustin Brito Del Pino

Industry Update
Susanne Ausborn, PhD


Speakers
avatar for Nélio Cézar de Aquino

Nélio Cézar de Aquino

General Manager of Medicines, ANVISA, Brazil
Nélio Cézar de Aquino is the General Manager of Medicines at the Brazilian Health Regulatory Agency (Anvisa). He has held various positions at Anvisa, including General Manager of Information Technology, Ports, Airports, Borders, and Customs Warehouses, Public Quality Control Laboratories... Read More →
avatar for Susanne Ausborn

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland
Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
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 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 →
AB

Agustin Brito Del Pino

Regional Regulatory Hub Team Lead, Pfizer Inc, Uruguay
avatar for Lawrence Yu

Lawrence Yu

Director, Office of New Drug Products, OPQ, CDER, FDA, United States
Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food and Drug Administration and Rapporteur, ICH M4Q(R2) Expert Working Group. Dr. Yu is also an adjunct Professor at the University of Michigan. Dr. Yu is an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session