DIA Europe 2019: Directory

Rustam Abdussalamov

National Center For Expertise of Medicines, Medical Devices and Medical Equipmen

Chief Development Officer

Virginia Acha

MSD, United Kingdom

Global Lead, Global Regulatory Policy

Mitzi Allred

Merck & Co., Inc., United States

Director, Clinical Operations

Susana Almeida

Medicines for Europe

Clinical Development and Safety Director

Hassaan S Alwohaibi

Saudi Food and Drug Authority

Executive Director of Regulatory Affairs Directorate

AA

Ana-Eva Ampelas

European Commission

Head of Unit, Medical products: Quality, Safety, Innovation

Charlotte Anderberg

Dental and Pharmaceutical Benefits Agency

Pharmaceutical Assessor

Artem Andrianov

Cyntegrity Germany GmbH

CEO

RA

René Anour

AGES

Senior Clinical Expert

Francis Arickx

National Institute for Health and Disability Insurance (RIZIV-INAMI)

Head of the Directorate Pharmaceutical Policy

Valdo Arnera

ERT

General Manager, Europe

CA

Carmen Arques

AZIERTA

Pharmacovigilance Manager

SA

Scott Askin

Novartis

Digital Solutions Director

Nadia Assenova

Sage Therapeutics

Head Regulatory Affairs Europe

Dimitrios Athanasiou

WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS

Patient Advocate

Susanne Ausborn

Hoffmann-La Roche Ltd

Regulatory Policy Lead

Peter Bachmann

Federal Institute for Drugs and Medical Devices (BfArM), Germany

Deputy-Head, European Union and International Affairs

Arton Baftiu

Norwegian Medicines Agency

Scientific Officer

DB

Dominic Balog-Way

King's College London

Research Associate

BB

Brendan Barnes

EFPIA

Director, Multilateral Issues and Health Policy

BB

Brendan Barnes

EFPIA

Director IP & Data Protection

WB

Walter Beck

Bayer AG

VP RD CO Head of Business Excellence & Innovation

Alun Bedding

Roche/Genentech

Director, Biostatistics

Nicola Bedlington

European Patient's Forum

Secretary General

Isabelle Bekeredjian-Ding

Paul-Ehrlich-Institut (PEI)

Head of Division of Microbiology

SB

Simon Bennett

Biogen

Director, EU Regulatory Policy

Conny Berlin

Novartis Pharma AG, Switzerland

Global Head, Quantitative Safety and Epidemiology

Cécile Bertin

F. Hoffmann La Roche LTD.

Associate Regulatory Program Manager

Trishna Bharadia

-

Patient Advocate, International Speaker, Writer, Advisor and Content...

KB

Kirstin Blackwell

Luto Research Ltd

Senior Manager

TB

Theo Blaise

Universite Claude Bernard Lyon

Pharmacy resident - Master degree

GB

Gerd Bode

Honorable Member of the Medical Faculty, Department of Pharmacology Toxicology

University of Goettingen

Peter Bogaert

Covington & Burling LLP

Partner

Claus Bolte

Swissmedic, Switzerland

Head of Authorisation

EB

Elena Bonfiglioli

Microsoft

Managing Director, Health and Life Sciences

WB

Wolfgang Bonitz

Novartis Pharma GmbH

Chief Scientific Officer

Gerrit Borchard

University of Geneva

Pedro Borga

Lifescience Dynamics Ltd

Consultant

FB

Frederic Bouder

University of Stavanger

Professor in Risk Management

Bruno Boulanger

PharmaLex

Chief Scientific Officer

Pascal Bouquet

Novartis

Global Head of Technology, Architecture and Digital for the Drug...

Carmen Bozic

Biogen

SVP, Portfolio Transformation

NB

Nihan Burul Bozkurt

Turkish Medicines and Medical Devices Agency (TITCK)

Head of the Clinical Trials Department

Romuald Braun

AMPLEXOR Life Sciences

Vice President, Strategy - Life Sciences

Karl Broich

Federal Institute for Drugs and Medical Devices (BfArM), Germany

President

Marloes van Bruggen

F.Hoffmann-La Roche Ltd.

Regional Regulatory Policy Lead

Marieke De Bruin

Copenhagen University

Director, Copenhagen Centre for Regulatory Science

Nikolai Brun

Danish Medicines Agency, Denmark

Co-Chair, EMA-MHA Big Data Task Force; Dir, Div for Medical Eval...

Philippe De Buck

FAGG-AFMPS

Head of Authorisations

Jennifer Burgess

TransCelerate BioPharma, Inc., United States

Vice President, Global Engagement and Communications

Andy Bushell

Oonida

CEO, OoNiDa

Bill Byrom

Signant Health

Vice President, Product Strategy and Innovation

Jorge Camarero

Spanish Agency For Medicines

CHMP Alternate

FC

Fiona Carlin

Baker McKenzie

Partner

Tania Cecilia Cavaliero

Swissmedic

Preclinical Assessor

HC

Hacer Coskun Cetintas

Turkish Medicines and Medical Devices Agency (TITCK)

Head of the Medicines Marketing Authorization Department

JC

Jianqing Chang

Tigermed Consulting Ltd., China

Vice President, Drug Regulatory Policy

Inas Chehimi

Novartis Pharma Services AG

Head DRA Middle East & North Africa

MC

Magda Chlebus

EFPIA

Executive Director Science Policy & Regulatory Affairs

Disa Lee Choun

UCB Celltech

Head of Innovation, Global Clinical Services and Operations

Klaus Cichutek

Paul-Ehrlich-Institut

President

Ingeborg Cil

Shire Now Part of Takeda

Lead, Clinical Trial Data Anonymization

DC

Douglas Clark

NA

Scott Cleve

Boehringer Ingelheim

Head of Global Regulatory Operations

EC

Eric Cohen

Abbvie

Medical Director

Evi Cohen

Appian

Vice President, Global Life Sciences & Healthcare

Emer Cooke

World Health Organization (WHO)

Director of Regulation of Medicines and other Health Technologies

Matt Cooper

NIHR Clinical Research Network

Business Development and Marketing Director

Sophie Cooper

National Institute for Health and Care Excellence (NICE)

Scientific Adviser

Solange Corriol-Rohou

AstraZeneca

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe

Amelia Cupelli

AIFA

Senior Pharmacovigilance Assessor, PRAC member

KC

Kosta Cvijovic

Syneos Health

EU QPPV

Gaby Danan

NA

Pharmacovigilance Expert

Jessica Davies

F. Hoffmann-La Roche Ltd

Senior Data Scientist, RWD Collaborations

Richard Davies

CluePoints

Vice President, Solution Expert

Dave deBronkart

e-Patient Dave

Speaker

Laurent Desqueper

MSD Europe

XEVMPD-IDMP Regional Business Lead

Petra Doerr

Swissmedic

Deputy Executive Director

Sreemanee Dorajoo

Health Sciences Authority, Singapore

Data Analyst

Jennifer Doralt

Shire, Now Part of Takeda

Lead Medical Writer - Hematology/Oncology

Dinah Duarte

INFARMED, Portugal

Scientific Evaluation Unit, Directorate of Medicinal Products

João Duarte

Alexion, Astrazeneca Rare Disease, France

Director, Business Planning & Operations, Global Regulatory...

James Duhig

AbbVie, Inc.

Director, Patient Integration

Francoise Dumas-Sillan

Pfizer Italy

EU QPPV

Brian Edwards

NDA Group, United Kingdom

Principal Consultant, Pharmacovigilance and Drug Safety,...

LE

Lindsay Edwards

GSK

Vicki Edwards

AbbVie, Inc., United Kingdom

Vice President, Pharmacovigilance Excellence and International QPPV

Kristel Van der Elst

The Global Foresight Group

CEO

Menno Van Der Elst

Medicines Evaluation Board

PRAC member

Harald Enzmann

Federal Institute for Drugs and Medical Devices (BfArM)

Chair, CHMP; Head of European and International Affairs

Sini Eskola

European Federation of Pharmaceutical Industries and Associations (EFPIA)

Director Regulatory Affairs

Rocco Falchetto

International Porphyria Patient Network

President

AF

Alex Farrell

TransPerfect

Regional Director Business Development

Jane Feron

AstraZeneca UK Ltd

Risk Management Director

PF

Pisana Ferrari

PHA Europe, European Pulmonary Hypertension Assoc.

Vice President

LF

Lisa Ferstenberg

AstraZenca

Principal Patient Safety Physcian

RF

Reinhard Fescharek

CSL Behring GbmH

Vice President

Chrissie Fletcher

Amgen Ltd

Executive Director, Biostatistics in Global Biostatistical Science

Frederik Floether

IBM

IBM Q Consulting Global Life Sciences Leader, Quantum & AI

Michael Forstner

PrimeVigilance

Senior Vice President, Head of Risk Management and...

MF

Miguel Forte

Chief Executive Officer

Emma Du Four

Abbvie

Head of International Regulatory Policy

Shelley Gandhi

NDA Group

Strategic Advisor, Pharmacovigilance and Drug Safety

UG

Ursula Garczarek

Cytel

Associate Director, Strategic Consulting

Marie Gardmark

Swedish Medicines Agency (MPA), Sweden

Head of Licensing

ZG

Zoe Garrett

National Institute for Health and Care Excellence (NICE)

SeniorTechnical Adviser – EUnetHTA

Patrick Gassenbauer

MSD Sharp & Dohme GmbH

QA Specialist

Jan Geissler

Patvocates

CEO

PG

Peter Gocke

Charité Berlin

Chief Digital Officer

Wim Goettsch

Dutch National Health Care Institute (ZIN)

Special Advisor HTA

Kate Gofman

Astrazeneca

Safety Physician

Martim Goncalves

IQVIA

Global Solutions Manager (R&D)

RG

Ravi Gopalakrishnan

AstraZeneca

Head of Digital Platform and Applications

Dmitriy Goryachev

Center of Expertise and Quality Control of Medicinal Products, Moh Russian Feder

Director

AG

Amelie Goyer

Nestec Ltd.

Clinical Project Manager

Marco Greco

European Patients’ Forum, Belgium

President

Michelle Grimes

Merck and Co., Inc., Denmark

Head, International Pharmacovigilance. GCS&PV

Irena Guzina

HAS

Scientific Project manager

David Haerry

European AIDS Treatment Group

Member

Ian Hamilton

Eli Lilly and Company

Medical Affairs Global IT Account Manager

Elizabeth Hancox

GSK

Deputy QPPV and Head of Safety Governance

Michael Happich

Eli Lilly

HTA director

Florent Hartmann

Novartis Pharma AG

Regulatory Sub-Region Head

Sabine Haubenreisser

European Medicines Agency, Netherlands

Principal Scientific Administrator, Stakeholders and Communication...

Annemarie Haverhals

Independent Consultant On VBHC

Adam Heathfield

Pfizer

Senior Director, Patient and Health Impact

Niklas Hedberg

Dental and Pharmaceutical Benefits Agency, TLV, Sweden

Chair EUnetHTA Executive Board; Chief Pharmacist

LH

Lisa Hedman

World Health Organisation

CH

Clara Heering

Johnson & Johnson

Enterprise JJCO lead for Capacity & Alliance Management

Esa Heinonen

Finnish Medicines Agency (Fimea)

Director, Assessment of Medicinal Products

Bruce Hellman

uMotif

CEO and Co-founder

Robert Hemmings

Medicines and Healthcare products Regulatory Agency (MHRA)

Statistics and Pharmacokinetics Unit Manager

EH

Esteban Herrero-Martinez

Abbvie Ltd

Director Regulatory Policy and Intelligence

TH

Tuyen Ho

Welocalize Life Sciences

VP of Market and Corporate Development

MH

Mike Holmes

MSD

Associate Vice President, Global Medical Affairs Oncology

Benjamin Horbach

F. Hoffmann-La Roche

François Houyez

European Organisation for Rare Diseases (EURODIS), France

Information and Access Director, Health Policy Advisor

Kenneth Hu

Rutgers University/Ernest Mario School of Pharmacy

Postdoctoral Fellow

Ian Hudson

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Chief Executive

KH

Karl-Heinz Huemer

Austrian Medicines and Medical Devices Agency (AGES)

Clinical Assessor, Scientific Office

Wendy Huisman

Vigifit, Netherlands

Director

Anthony Humphreys

European Medicines Agency (EMA)

Head of Scientific Committees Regulatory Science Strategy

Berthold Huppertz

Medical University of Graz

Chair, Division of Cell Biology, Histology and Embryology

Hugo Hurts

Medicines Evaluation Board (MEB)

Chair HMA Task Force; Executive Director

Simon Ingate

Huron Consulting Group

Director

Malin Jakobsson

Uppsala Monitoring Centre

Product Strategy Manager

Merete Joergensen

Novo Nordisk A/S

Senior Trial Disclosure Director, Global Clinical Registry

Angelika Joos

Merck Sharp & Dohme (Europe) Inc., Belgium

Executive Director, Global Regulatory Policy

Greg Jordinson

Janssen R&D

Associate Director, Global Regulatory Affairs

EJ

Etienne Jousseaume

Novartis

Head Market Access Cell and Gene Europe

LK

Lindsay Kadjidja

Institut De Pharmacie Industrielle De Lyon

Student

CK

Chitkala Kalidas

Bayer

VP and Head Oncology Regulatory Affairs

OK

Oksana Karavaeva

IPHARMA LLC

ClinOps Director

Srinivas Karri

Oracle Corporation

Senior Director, Clinical Warehousing Cloud Strategy

MK

Maureen Kenny

Informa

EXECUTIVE EDITOR

RK

Ryan Kilpatrick

AbbVie

Global Head, Epidemiology

DK

Diane Kleinermans

Ministry of Health and Social Affairs

Advisor

MK

Manfred Koehler

Koehler eClinical GmbH

CEO

Beata Kolon

ICON

Director Medical Safety Services

Hideyuki Kondo

Pharmaceuticals and Medical Devices Agency (PMDA)

Deputy Director, Office of International Program

Tatsuya Kondo

Pharmaceuticals and Medical Devices Agency (PMDA)

Chief Executive

Wolfgang Kothny

Novartis Pharma, Switzerland

Global Head Clinical Sciences

Oguzhan Koyuncu

Turkish Medicines and Medical Devices Agency (TITCK)

Advisor to the President

Jürgen Kübler

QSciCon

Owner

Thomas Kühler

Sanofi R&D, France

Head GRSP EU/AMEE

LK

Lembe Kullamaa

European Patients' Forum

Representative Estonian Chamber of Disabled People at EPF Youth Group

Barbara Lopez Kunz

DIA, United States

Global Chief Executive

Sandra Kweder

FDA, United States

Deputy Director, Europe Office, Office of Global Programs and...

Julia Lakeland

Parexel, United Kingdom

Senior Director,Sensor Solutions

LL

Linda Landells

National Institute for Health and Care Excellence (NICE)

Associate Director Technology Appraisals (Cancer Drugs Fund)

Niels Leander

NNIT

Consulting Director

AL

Adelina Lear

ICON plc

Strategic Account Executive

Hans Lehrach

Max Planck Institute for Molecular Genetics

Director

EJ

Evert Jan van Lente

AOK Bundesverband (Federal Insurer)

Director EU-Affairs

IL

Iain Leslie

F. Hoffmann-La Roche

Health Outcomes Manager, Communications, Policy and Access Directorate

Hubert Leufkens

Utrecht University

Professor, Pharmaceutical Policy and Regulatory Science

David Lewis

Novartis Pharma AG, Switzerland

Head QPPV PRRC Office, Chief Medical Office & Patient Safety

Beatriz Silva Lima

NDA Advisory Services Limited

Professor of Pharmacology; NDA Advisory Board

Mika Lindroos

Signant Health

Director, Product Management, eConsent

Lenita Lindström-Gommers

European Commission

ICH Assembly Chair and Senior Expert, European Commission

Rory Littlebury

Medicines and Healthcare products Regulatory Agency (MHRA)

Pharmacovigilance Inspector

JL

Johan Liwing

Janssen

Director Market Access RWE Partnerships, Global Commercial Strategy...

RL

Ragnar Lofstedt

Kings College London

Professor of Risk Management

Murray Lumpkin

Bill and Melinda Gates Foundation, United States

Deputy Director, Integrated Development, Lead for Global Reg Systems...

Gavin Lyndon

Pfizer

Global Lead, Content Strategy and Management – Medical Information

Judith Macdonald

Pfizer

Head of Global Regulatory Policy & Intelligence

Souzi Makri

Cyprus League Against Rheumatism

Vice-President

Marie Manley

Sidley Austin LLP, United Kingdom

Partner, Head of EU and UK Life Sciences (UK)

SM

Susan Manoff

MSD

Executive Director

Friedrich Maritsch

Shire Now Part of Takeda

Data Anonymization Lead

David Martin

FDA

Associate Director for Real World Evidence Analytics, OMP, CDER

Agnes Mathieu-Mendes

European Commission

Deputy Head of Unit

MM

Matthew May

EUPATI

Programme Coordinator, EUPATI Project

CM

Christine Mayer-Nicolai

EMD Serono

Global Head, Global Regulatory and Scientific Policy

AM

Amy McKee

FDA

Deputy Director FDA/Oncology Center of Excellence

NM

Nick Meade

Genetic Alliance UK

Director of Policy

Suzanne Meenan

Roche Products Ltd, UK, United Kingdom

Medical Information Group Lead

DM

Daniela Melchiorri

University of Roma

Member CHMP

CM

Camille Metais

Alexion Pharma GmbH

Senior Director Regulatory Affairs

Thomas Metcalfe

F. Hoffmann-La Roche

Data Policy Leader, Personalised Healthcare