Speakers

Stefano Accorsi

Head of Global Regulatory Intelligence and Policy

Chiesi Farmaceutici

Qutaiba Al Manaseer

Government Affairs Director

AstraZeneca

Khalid Al-Kinani

Head of the Biologics and Biosimilars Registration Committee

Iraqi Ministry of Health

Abebe Alamneh, B Pharm, MSc,

Senior Medicine Registration Expert

Ethiopian Food and Drug Authority (EFDA)

Mario Alanis, PhD

Senior Advisor

CIRS - Centre for Innovation in Regulatory Science

Ana Montoya Alarcon

Director Regulatory Systems Lead

Daiichi Sankyo

Faraat Ali

Manager, Department of Inspection and Enforcement, Laboratory Services

Botswana Medicines Regulatory Authority (BOMRA)

Nawaf Almutairi

Regulatory Affairs Expert

Saudi Food and Drug Authority

Yuricel Tamayo Alvarez

Regulatory Affairs Specialist

Roche Ecuador S.A.

Prof. Soha Aly Aly Elmorsy

Head of Pharmacology Department

Faculty of Medicine Cairo University

Kepa Amutxastegi Gabiola

Associate Director Regulatory Information Management

Merck KGaA Darmstadt Germany

Craig Anderson

Director, R&D Labeling Lead

Pfizer

Paul Attridge

VP Vault RIM, Enterprise

Veeva

Zainab Aziz

Associate Director RA Policy and Strategic Operations- SSA

Novartis

Kristina Bayramyan

Director, Regulatory Policy, Emerging Markets

GSK

Jason Berning

Associate Business Development Director - Regulatory Technology Solutions

IQVIA

Marcin Boruk

Senior Policy Analyst

Health Canada | Santé Canada

Céline Bourguignon

Head, Greater China and Intercontinental & Emerging Markets Regulatory Policy

GSK

Bobby Bouthillette

Global Director, Quality & Regulatory

Dassault Systèmes

Lawrence Callahan

Chemist

FDA, USA

Alan Chalmers

Owner

Pharma International

Isabel Chicharo

Head of Regulatory Data Management Service

EMA

Filip Cvetanovski

Regulatory Affairs

ALKALOID AD Skopje

Quentin Darrasse

Regulatory Data Strategy Principal

Roche

Jolanda de Bruijn

Senior Manager, Global Regulatory Operation

Jazz Pharmaceuticals

Alaitz De Eguía y López

Operations Lead Structured Data Submissions

Sanofi

Hannie de Munnik

Executive Director EUCAN Regulatory Affairs

AstraZeneca

Andrew Deavin

Senior Director, Global Regulatory Affairs

GSK

Maxime Delpire

Regulatory Information Management Expert

Ennov

Laurent Desqueper

IT Regulatory Affairs & QA

UCB

Polina Dombure

CEO

Inpharmatis Group

Teresa Eastwood-Kiefer

Regulatory Data and Content Chapter Leader

Roche

Andrea Fischer

Global Head Regulatory Operations – IT Systems & Digital

Sandoz

Sebastian Fischer

Regulatory Strategy Principal

TÜV SÜD Product Service GmbH

Martin Fitzgerald

Director Digital Health and Public Policy Healthcare

GS1

Eileen Flood

Associate Director, Business Outcomes Delivery (Regulatory Information Management)

Johnson & Johnson

Jean-Gonzague Fontaine

Product and Substance Master Data Lead, Vx

GSK Vaccines

Andreas Fürer

Regulatory Manager

SwissMedic

Mustafa Ghafouri

Lead Data Architect

Doctor Data

Matthias Glatz

Principal Product Manager, Digital for Development

Moderna

Edoardo Gnavi

Senior R&D Business Consultant

Veeva Systems

Diego Alejandro Gutiérrez Triana

Regional Regulatory Director - Colombia

Udela

Ali Hansford

Director of Regulatory Innovation Strategy & Policy (Europe)

Accumulus Synergy

Anna Hanzlíková

Senior Director, Global RA, Regulatory Head, Europe and ROW

NOVAVAX CZ a.s.

Christian Hay

Sr Advisor Healthcare

GS1 Global Office

Karin Hay

Policy Analyst

Health Canada

Matthias Heck

Head of EU Government Affairs & Strategic Alliance Development

Alexion Pharmaceuticals

Luisa Heesen

Business Data Domain Owner Products and Substances

Boehringer Ingelheim

Suzie Henderson

Associate Director, Regulatory Affairs

Shionogi Europe

Marcel Hoefngel

Assessor, Biopharmaceuticals

College ter Beoordeling van Geneesmiddelen - Medicines Evaluation Board (CBG-MEB)

Christina Juli

Head of CMC Management CMB

Boehringer Ingelheim

Michael Kempf-Hamm

Senior Manager Data & Process Integration

Boehringer Ingelheim

Thomas Kirchlechner

Director Regulatory Policy & Intelligence

Sandoz

Anna Kispál

Product Manager

LORENZ Life Sciences Group

Jesper Kjær

Global Director for Public, Private Partnerships, StratOps, Global Medical Affairs

Novo Nordisk, Denmark

Olof Lagerlund

Substance Expert

Uppsala Monitoring Centre

Niels Leander

Vice President, R&D Consulting

NNIT

Laurent Lefebvre

Regulatory CMC Director

Novartis Pharma AG

Alessandra Leone

CMC Director, I&I

Pfizer

Lawrence Liberti

Director

The D. K. Kim International Center For Regulatory Science

Veronica Lipucci Di Paola

Master Data Manager at European Medicines Agency

EMA

Geraldine Lissalde-Bonnet

Vice President Healthcare

GS1 Global

Anna Litsiou

Regulatory Policy & Intelligence Director - International & China

AstraZeneca

Dmytro Lurye

Project Manager

Medicines for Europe

Balázs Lázár

Head of Global Regulatory CMC & Operation Department

Gedeon Richter

Danini Marin

Independent Consultant

Regulatory Affairs

Karin Markgraf

Head of Regulatory Affairs Asia Pacific

Merck Group

Abdul Mateen

Director

Healthcare Consultancy Services

Olivia McDermott

Associate Professor in Regulatory Affairs & Operational Excellence

University of Galway

Patrick Middag

Principal Regulatory Affairs Lead

Servier

Anne Moen

Coordinator

Gravitate Health & Professor, University of Oslo

Kholoud Mohamed

Clinical Technical Support Unit Manager

Egyptian Drug Authority

Belinda Mudhobhi

Pharmaceutical Innovation Strategy and Regulation Specialist

AfricaBio

Remco Munnik

Vice President

IRISS Forum

Darius-Jean Namdjou

Director, Senior Regulatory Lead

Phortas GmbH

Abita Nanda

Chapter Lead, Regulatory Innovation and Sustainment

Genentech

Koen Nauwelaerts

Regulatory Policy and Innovation Lead

Bayer

Rakesh Neelam

Sr Specialist- Digital Innovation & Systems - Regulatory Planning & Publishing

MSD

Alastair Nixon

Senior Director, Data Strategy

GlaxoSmithKline Research & Development Limited, UK

Heiner Oberkampf

CEO and Co-Founder

Accurids

Ana Padua

Director EU Global Regulatory and Scientific Policy

Merck HealthCare

Rodrigo Palacios

Global Regulatory Policy Lead

F. Hofmann-La Roche

Raj Patra

Global IT & Digital Lead - R&D, Safety, PLM, Quality, Regulatory Affairs & Compliance

Reckitt

Josef Pellizarri

Managing Director

Pellizzari Consulting GmbH

Vada A Perkins

Executive Director, Regulatory Policy & Intelligence/Head, Regulatory Intelligence

Bayer Pharmaceuticals

Boris Pleten

Head of Registration Department of the EAEU

Gedeon Ritcher

Kristiina Puusaari

eSubmissions Programme Management

EMA

Renato Rjavec

Senior Director, Regulatory Product Management

ArisGlobal

Catherine Russell

Data Architect (Taxonomy)

Medicines and Healthcare Products Regulatory Agency (MHRA)

Elizabeth Scanlan

Scientific Communication Officer & ePI Product Owner

European Medicines Agency (EMA)

Rainer Schwarz

Business Consultant

KlearDoc/ LORENZ Life Sciences Group

Alessandra Sech

Regulatory Operations Manager

Tiefenbacher Group

Nathan Seyoum

Medicine Registration Expert /Co founder and Regional Coordinator

East Africa Regulatory Affairs Professionals Association (EARAPA)

Andreas Skarpis

Senior Submissions Manager

Roche

Anna Sokołowicz

Director, e-Submission Strategy and Process

GSK

Michiel Stam

Management Consultant and Senior Regulatory Expert

MAIN5

Pierre Stanislawski

Product Director

Ennov

Jelle Stans

Regulatory Affairs Manager

European Organisation for Research and Treatment of Cancer (EORTC)

Martin Steinmann

Developing a Data Governance Strategy

CSL Behring

Frits Stulp

Chairman of the Board

CTADHL

Jörg Stüben

Head of Regulatory Information Management and Senior Expert

Boehringer Ingelheim International GmbH

Jianhui Sun

Regulatory Affairs Manager APAC Region

SEPTODONT

Janaki Suriyanarayanan

Senior Manager Regulatory Information Management

Merck KGaA Darmstadt Germany

Lucie Svobodová

Senior Manager, Regulatory Affairs

Novavax

Morad Tahani

Associate Director - IT Lead Regulatory

UCB

Kwee-Lan Tan

Regional Regulatory Lead, Emerging Markets

Boehringer Ingelheim

Aneta Tyszkiewicz

Director Digital and Data

European Federation of Pharmaceutical Industries and Associations (EFPIA)

Laura Valtere

Guest Lecturer

Riga Graduate School of Law

Hans van Bruggen

Chief Scientific Officer

Celegence

Maren von Fritschen

Head Regulatory Policy EU

Moderna