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19th Regulatory and Scientific Affairs Conference, Amsterdam

Amsterdam
© PDC
datum 30 januari 2020 - 31 januari 2020
plaats Amsterdam
locatie HILTON HOTEL, Amsterdam Toon locatie
organisatie Medicines for Europe

2020 PROGRAMME

REGISTER NOW

HOTEL ACCOMMODATION

Please book your accommodation by phoning +31-(0) 20-7106014 or sending an email to carlijn.swagemakers@hilton.com

ADVERTISING, EXHIBITION & SPONSORSHIP OPPORTUNITIES

Join the Medicines for Europe 19th Regulatory and Scientific Affairs Conference 30- 31 January 2020 to further your knowledge on recent regulatory and scientific hot topics affecting your daily work.

Learn from the best and meet the best! - engage in fruitful discussions with 200 participants including the competent authorities and well-known industry experts.

Meet the regulators- More than 60 representatives from the competent authorities attended our regulatory conference last year.

Don’t miss this opportunity in 2020!

Top Agenda topics for 2020

New EU political landscape - how will it impact the pharmaceutical regulatory environment?

Why is now the right time to modernise the EU Variations system?

Regulatory measures to respond better to issues of medicines shortages

Digital Technology and automation - what opportunities are there for the regulatory environment?

From document to data driven process - is the regulatory environment ready?

Streamlining global development of generic medicines: hope vs. hype

Is the current regulatory framework supportive of developing more complex off-patent medicines?

Watch this space in 2020!

Outcome of the recent court cases affecting regulatory strategy

Implementation of the Medical Device Regulation - are we going to meet the implementation deadline?

Special Session

Put your questions to the Regulators. An opportunity to address questions to the European Regulators

CHAIRPERSONS AND SPEAKERS

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Christoph Stoller

Senior Vice President Teva and President Medicines for Europe

Christoph StollerSenior Vice President Teva and President Medicines for Europe

Adrian van den Hoven

Director General, Medicines for Europe

Adrian van den HovenDirector General, Medicines for Europe

Guido Rasi

Executive Director, EMA

Guido RasiExecutive Director, EMA

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority (HPRA) (IE) a Member of the Heads of Medicines Agencies (HMA) Management Board

Lorraine NolanChief Executive, Health Products Regulatory Authority (HPRA) (IE) a Member of the Heads of Medicines Agencies (HMA) Management Board

Rúna Hauksdóttir Hvannberg

Executive Director, Icelandic Medicines Agency IMA (IS)

Rúna Hauksdóttir HvannbergExecutive Director, Icelandic Medicines Agency IMA (IS)

Prof. Dr. med. Karl Broich

President, BfArM (DE)

Prof. Dr. med. Karl BroichPresident, BfArM (DE)

Beata Stepniewska

Deputy Director General and Head of Regulatory Affairs, Medicines for Europe

Beata StepniewskaDeputy Director General and Head of Regulatory Affairs, Medicines for Europe

Caroline Kleinjan

Chair of the Regulatory and Scientific Affairs Committee Medicines for Europe, Sandoz

Caroline KleinjanChair of the Regulatory and Scientific Affairs Committee Medicines for Europe, Sandoz

Koen Laenen

Regulatory Affairs and Quality Manager, Medicines for Europe

Koen LaenenRegulatory Affairs and Quality Manager, Medicines for Europe

Esther Martinez

Scientific Administrator, Manufacturing Quality and Supply Chain Integrity, Committees and Inspections, EMA

Esther MartinezScientific Administrator, Manufacturing Quality and Supply Chain Integrity, Committees and Inspections, EMA

Andrzej Rys, Dr

Director Health Systems, Medical Products and Innovation, DG SANTE - European Commission

Andrzej Rys, DrDirector Health Systems, Medical Products and Innovation, DG SANTE - European Commission

Laure Geslin

Head of Division Proper Use, FAMHP (Belgium)

Laure GeslinHead of Division Proper Use, FAMHP (Belgium)

Sandra L. Kweder, M.D.

Deputy Director Europe Office, Liaison to the European Medicines Agency, US FDA

Sandra L. Kweder, M.D.Deputy Director Europe Office, Liaison to the European Medicines Agency, US FDA

Giorgio Riccò

Teva Pharmaceuticals

Giorgio RiccòTeva Pharmaceuticals

Geraldine Moore

Mylan

Geraldine MooreMylan

Susanne Winterscheid

BfArM (DE)

Susanne WinterscheidBfArM (DE)

Hélène Bruguera

EDQM

Hélène BrugueraEDQM

Florian Schmidt

DG SANTE

Florian SchmidtDG SANTE

Astrid Krupp

Vice President Regulatory Affairs, Business Unit Generics and Complex Formulations ELAMA & Asia Pacific, Fresenius Kabi Deutschland GmbH

Astrid KruppVice President Regulatory Affairs, Business Unit Generics and Complex Formulations ELAMA & Asia Pacific, Fresenius Kabi Deutschland GmbH

Sarah Faircliffe

Legal Director, Bird & Bird

Sarah FaircliffeLegal Director, Bird & Bird

Koosje van Lessen Kloeke

Leijnse Artz

Koosje van Lessen KloekeLeijnse Artz

Sonia Ribeiro

EMA

Sonia RibeiroEMA

Susana Almeida, PhD

Clinical Development and Safety Director, Medicines for Europe

Susana Almeida, PhDClinical Development and Safety Director, Medicines for Europe

Nivedita Valentine

Franchise Development Director, Added Value Products, Accord Healthcare

Nivedita ValentineFranchise Development Director, Added Value Products, Accord Healthcare

Pavel Farkas

Senior Director Global Generics Clinical R&D, Teva

Pavel FarkasSenior Director Global Generics Clinical R&D, Teva

Augusto Filipe, Dr. MD

Head of the Medical Department and QQPV, EudraVigilance Representative, Tecnimede

Augusto Filipe, Dr. MDHead of the Medical Department and QQPV, EudraVigilance Representative, Tecnimede

Jan Welink

MEB (NL)

Jan WelinkMEB (NL)

Fakhredin Sayed Tabatabaei

MEB (NL)

Fakhredin Sayed TabatabaeiMEB (NL)

Anjana Pindoria

Extedo

Anjana PindoriaExtedo

Juan García-Burgos

Head of Public Engagement Department, European Medicines Agency (EMA)

Juan García-BurgosHead of Public Engagement Department, European Medicines Agency (EMA)

Georg Neuwirther

Head of IT, Austrian Medicines and Medical Devices Agency (AGES MEA)

Georg NeuwirtherHead of IT, Austrian Medicines and Medical Devices Agency (AGES MEA)

Peter Bachmann

Head 'International Liason Office and Conferences', Executive Department ‘European Union and International Affairs’, Federal Institute for Drugs and Medical Devices (BfArM), DE

Peter BachmannHead 'International Liason Office and Conferences', Executive Department ‘European Union and International Affairs’, Federal Institute for Drugs and Medical Devices (BfArM), DE

Kevin Airey

Director Regulatory Affairs EMEA Affiliates, Mylan

Kevin AireyDirector Regulatory Affairs EMEA Affiliates, Mylan

Britt Vermeij

TEVA

Britt VermeijTEVA

Katarina Nedog

Head Business Process & Excellence Information Management & Systems, Global Regulatory Affairs, Sandoz

Katarina NedogHead Business Process & Excellence Information Management & Systems, Global Regulatory Affairs, Sandoz

Stephanie Kohl

Policy & Advocacy Officer of the European Association of Hospital Pharmacist (EAHP)

Stephanie KohlPolicy & Advocacy Officer of the European Association of Hospital Pharmacist (EAHP)

Ellen Swanborn

Chairman, Dutch Skin Patients Organization (Huidpatiënten Nederland)

Ellen SwanbornChairman, Dutch Skin Patients Organization (Huidpatiënten Nederland)

Lei Zhang, Ph.D.

Office of Research and Standards (ORS), Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)

Lei Zhang, Ph.D.Office of Research and Standards (ORS), Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)

Dr. Luther Gwaza

Technical Officer, World Health Organization (WHO)

Dr. Luther GwazaTechnical Officer, World Health Organization (WHO)

Remco Munnik

Associate Director, Iperion Life Sciences Consulting

Remco MunnikAssociate Director, Iperion Life Sciences Consulting

Isabel Chicharo

Head of Data and Information Lifecycle Management Service Deputy Programme Manager for the SPOR/IDMP Programme, EMA

Isabel ChicharoHead of Data and Information Lifecycle Management Service Deputy Programme Manager for the SPOR/IDMP Programme, EMA

Stuart Izod

Head Regulatory Information Management, Global Regulatory Affairs, Teva

Stuart IzodHead Regulatory Information Management, Global Regulatory Affairs, Teva

Laura Oliveira Santamaria

Chair of the CMDh, AEMPS (ES)

Laura Oliveira SantamariaChair of the CMDh, AEMPS (ES)

Kora Doorduyn-van der Stoep

Vice-Chairperson CMDh, NL-CMDh Member/Senior Policy Adviser Medicines Evaluation Board (MEB) (NL)

Kora Doorduyn-van der StoepVice-Chairperson CMDh, NL-CMDh Member/Senior Policy Adviser Medicines Evaluation Board (MEB) (NL)

Jitka Vokrouhlická

SUKL (CZ)

Jitka VokrouhlickáSUKL (CZ)

Ana López de la Rica Manjavacas

CMDh Member for Spain, AEMPS (ES)

Ana López de la Rica ManjavacasCMDh Member for Spain, AEMPS (ES)

Sabina Uzeirbegović

HALMED (HR)

Sabina UzeirbegovićHALMED (HR)

See highlights from our 2019 event

Video

Photo Gallery

Press Release

To secure your place at this ‘must attend’ platform, please register now and you too can share information with leading experts and network with your peers.

Follow the event on Twitter: #RAC20

CONFERENCE SPONSOR

Medicines for Europe is honored to be collaborating with the following partners to make this year’s conference

Inhoud

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CONTACT

Lucia Romagnoli

M: +44 (0) 7 562 87 68 73

For more information on advertising, exhibition and sponsorship packages:

Trudy Beks

M: +31 6 4119 0824

Media Requirements and Press Policy

For any other media enquiries:

Kate O’Regan

P: +32 (0)2 239 2019


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