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Tuesday, June 16 • 8:00am - 9:00am
#203 L: ICH 30th Anniversary Series: The Role of Multidisciplinary Topics

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-718-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide an overview of key ICH Multidisciplinary topics and current efforts to promote more efficient drug development and registration.

Learning Objectives

Discuss the role of the ICH multidisciplinary topics in harmonizing standards for more efficient pharmaceutical registration; Describe the role of standards development organizations (SDOs) and how they impact the development of ICH standards; Explain a new ICH harmonization effort to standardize organization and content of clinical protocols and development of a technical specification.

Chair

Amanda Marie Roache, MS

Speaker

ICH Data Standards and MedDRA
Mary Ann Slack

ICH M11 Clinical electronic Structured Harmonized Protocol
Ron Fitzmartin, PhD, MBA

ICH Electronic Standards for the Transfer of Regulatory Information
Vada A. Perkins, DrSc, MS, MSc



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 international regulatory policy, advocacy in... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of the Director, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →
avatar for Vada A. Perkins

Vada A. Perkins

Executive Director, Regulatory Policy and Intelligence, Bayer Pharmaceuticals
Vada A. Perkins, Bayer Pharmaceuticals, Executive Director, Regulatory Policy & Intelligence, Head Regulatory Intelligence- Vada A. Perkins, CAPT (ret) is a former FDA Senior Advisor for Regulatory Science and a recognized global regulatory policy & intelligence expert with regulatory... Read More →
avatar for Mary Ann Slack

Mary Ann Slack

Director, Office of Strategic Programs, CDER, FDA, United States
Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in... Read More →


Tuesday June 16, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session |   09: Regulatory, Session