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Wednesday, June 29 • 2:00pm - 3:15pm
#347: Global Harmonization: Non-ICH Regions

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Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Multinational pharmaceutical companies generally manufacture the same product the same way for every market, region, and patient around the world. This session will discuss how, in the emerging markets, divergent, nonscientific, regulatory standards are proliferating. Increased global divergence in regulatory requirements and review times unnecessarily increases manufacturing costs, complicates the supply chain, hinders science and risk-based approaches, increases collective regulatory burden, reduces continuous improvement and innovation, and delays delivery of medicines to patients.

Learning Objectives

Discuss the regulatory landscape in Latin America compared to ICH regions; Describe an industry perspective on science/risk-based life cycle management; Identify regulator perspectives on life cycle management challenges.

Chair

Annie W Sturgess, PhD

Speaker

The Challenges Handling Postapproval Changes in Latin America
Maria Cristina Mota, MBA

The New Postapproval Regulations from ANVISA
Ivone Takenaka

Opportunities for Improved Access to Safe and Efficient Medicines
Maria Guazzaroni Jacobs, PhD


Chair
AS

Annie Sturgess

Vice President, Global Regulatory Sciences, CMC, Bristol-Myers Squibb Company

Speakers
avatar for Maria Guazzaroni Jacobs

Maria Guazzaroni Jacobs

Director, Quality and Regulatory Policy (QRP), Pfizer Inc
Maria has 30+ years of Pharmaceutical industry experience mainly in Quality.With Pfizer since 1991; she managed analytical laboratories, including the Quality Control Laboratories, and was the Brooklyn Site Quality Operations Director prior to assuming a Center position. Current... Read More →
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

Director, Scientific Regulatory Policy and Intelligence - Latin America, AbbVie, Inc.
Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for Latin America. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →
avatar for Ivone Takenaka

Ivone Takenaka

Associate Director, GRSB-CMC and LATCAN Reg Expert, Bristol-Myers Squibb Company
Ivone Takenaka, Ph.D. is an Associate Director in Global Regulatory Affairs-CMC, and is the LA-Canada Regional Expert at Bristol-Myers Squibb Co. She earned her Ph.D. and MSc Degrees in Molecular Biology & Biochemistry from the University of Connecticut, CT; and MSc in QA&RA from... Read More →

Wednesday June 29, 2016 2:00pm - 3:15pm EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Session