Speakers

Speakers

Dr. Boitumelo Semete-Makokotlela

Dr. Boitumelo Semete-Makokotlela

Chief Executive Officer
South African Health Products Regulatory Authority

Cammilla Gomes

Cammilla Gomes

Roche
LATAM Regulatory Policy Lead

Christina Markus

Christina Markus

Partner and Deputy Chair, FDA & Life Sciences Practice
King & Spalding LLP

Cynthia Schnedar

Cynthia Schnedar

EVP-Regulatory Compliance
Greenleaf Health and Former FDA

Emma Ramnarine

Emma Ramnarine

Executive Director - Global Head External Development Collaborations
Genentech/Roche

Dr. Geoffrey Wu

Dr. Geoffrey Wu

Associate Director for Science and Communication, Office of Lifecycle Drug Products, OPQ, CDER
US Food and Drug Administration

Graham Carroll

Graham Carroll

GMDP Operations Manager and Senior Inspector
Medicines and Healthcare Products Regulatory Agency

Gustavo Mendes Lima Santos

Gustavo Mendes Lima Santos

General Manager - Medicines and Biological Products
ANVISA

Dr. Houri Simonian

Dr. Houri Simonian

Health Science - Director, Analytical Operations
SGS Lifesciences

Ivo Bucaresky

Ivo Bucaresky

Former Director
ANVISA

Dr. James Drinkwater

Dr. James Drinkwater

Head of GMP Compliance & Aseptic Process Integration
F Ziel GbmH

Jose Carlos Ferreyra

Jose Carlos Ferreyra

President
Mexican Pharmaceutical Institute

Dr. Joy St John

Dr. Joy St John

Executive Director
The Caribbean Public Health Agency

Julie Maréchal-Jamil

Julie Maréchal-Jamil

Director Biosimilar Policy & Science
Medicines for Europe

Julio Sánchez y Tépoz

Julio Sánchez y Tépoz

President
ALó ProScience and former Federal Commissioner COFEPRIS - Mexico

Dr. Kurt Brorson

Dr. Kurt Brorson

Vice President-Regulatory & Access
Parexel and Former FDA

Dr. M Madan Mohan Reddy

Dr. M Madan Mohan Reddy

Vice President - Quality and Regulatory
EISAI India

Dr. Mamta Gautam-Basak

Dr. Mamta Gautam-Basak

Senior Director-Regulatory Affairs CMC
Celldex and Former FDA

Maria Manley

Maria Manley

Partner and Head of UK Life Sciences
Sidley Austin LLP

Dr. María José Barragán

Dr. María José Barragán

Founder
Barragan BioConsulting and Former FDA

Marie Morin

Marie Morin

Principal Auditor
MFM GMP Consulting and Former FDA

Martin FitzGerald

Martin FitzGerald

Deputy Director General
European Healthcare Distribution Association

Dr. Mike Urquhart

Dr. Mike Urquhart

Scientific Director
GSK Pharmaceuticals, UK

Dr. Nagendran Irukulapati

Dr. Nagendran Irukulapati

Sr. Vice President – Global Regulatory Affairs
Aurobindo Pharma

Paula Marques

Paula Marques

Former VP-Regulatory Affairs, Latin America and Canada
Allergan

Philip Crooker

Philip Crooker

Former Regulatory Counsel
US FDA

Dr. Praveen Kumar L

Dr. Praveen Kumar L

Director – Regulatory Affair
Cipla

Rita Purcell

Rita Purcell

Deputy Chief Executive
Health Products Regulatory Authority

Robert Guidos

Robert Guidos

Executive Director-Pharma Regulatory Affairs & Strategic Alliances
Corning Incorporated and Former FDA

S.M Mudda

S.M Mudda

Managing Director
Misom Labs and Chairman of RA Committee, IDMA

Samar Darwish

Samar Darwish

Director-Drug Regulatory Affairs
Boehringer Ingelheim, Canada

Dr. Sarah Pope Miksinski

Dr. Sarah Pope Miksinski

Senior Director-Regulatory CMC/CMO
AstraZeneca

Stephen Murby

Stephen Murby

Board Member
Alliance for Safe Biologic Medicines

Sudarshan Jain

Sudarshan Jain

Secretary General
Indian Pharmaceutical Alliance

Sukanya Choudhury

Sukanya Choudhury

Executive Vice President - Regulatory Affairs
GSK Pharmaceuticals, India

Susan Paisley

Susan Paisley

Senior Application Manager
EXTEDO Inc

Dr. Xavier Luria

Dr. Xavier Luria

Chief Executive Officer
Drug Development and Regulation

Santosh Savarkar

Santosh Savarkar

Former Director Regulatory Affairs
Emcure Pharmaceuticals