19th Regulatory and Scientific Affairs Conference, Amsterdam - Main contents
| date | January 30, 2020 - January 31, 2020 |
|---|---|
| city | Amsterdam |
| location | HILTON HOTEL, Amsterdam  |
| organisation | Medicines for Europe |
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
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Senior Vice President Teva and President Medicines for Europe
Christoph StollerSenior Vice President Teva and President Medicines for Europe
Director General, Medicines for Europe
Adrian van den HovenDirector General, Medicines for Europe
Executive Director, EMA
Guido RasiExecutive Director, EMA
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
Executive Director, Icelandic Medicines Agency IMA (IS)
Rúna Hauksdóttir HvannbergExecutive Director, Icelandic Medicines Agency IMA (IS)
President, BfArM (DE)
Prof. Dr. med. Karl BroichPresident, BfArM (DE)
Deputy Director General and Head of Regulatory Affairs, Medicines for Europe
Beata StepniewskaDeputy Director General and Head of Regulatory Affairs, Medicines for Europe
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
Regulatory Affairs and Quality Manager, Medicines for Europe
Koen LaenenRegulatory Affairs and Quality Manager, Medicines for Europe
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
Director Health Systems, Medical Products and Innovation, DG SANTE - European Commission
Andrzej Rys, DrDirector Health Systems, Medical Products and Innovation, DG SANTE - European Commission
Head of Division Proper Use, FAMHP (Belgium)
Laure GeslinHead of Division Proper Use, FAMHP (Belgium)
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
Teva Pharmaceuticals
Giorgio RiccòTeva Pharmaceuticals
Mylan
Geraldine MooreMylan
BfArM (DE)
Susanne WinterscheidBfArM (DE)
EDQM
Hélène BrugueraEDQM
DG SANTE
Florian SchmidtDG SANTE
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
Legal Director, Bird & Bird
Sarah FaircliffeLegal Director, Bird & Bird
Leijnse Artz
Koosje van Lessen KloekeLeijnse Artz
EMA
Sonia RibeiroEMA
Clinical Development and Safety Director, Medicines for Europe
Susana Almeida, PhDClinical Development and Safety Director, Medicines for Europe
Franchise Development Director, Added Value Products, Accord Healthcare
Nivedita ValentineFranchise Development Director, Added Value Products, Accord Healthcare
Senior Director Global Generics Clinical R&D, Teva
Pavel FarkasSenior Director Global Generics Clinical R&D, Teva
Head of the Medical Department and QQPV, EudraVigilance Representative, Tecnimede
Augusto Filipe, Dr. MDHead of the Medical Department and QQPV, EudraVigilance Representative, Tecnimede
MEB (NL)
Jan WelinkMEB (NL)
MEB (NL)
Fakhredin Sayed TabatabaeiMEB (NL)
Extedo
Anjana PindoriaExtedo
Head of Public Engagement Department, European Medicines Agency (EMA)
Juan García-BurgosHead of Public Engagement Department, European Medicines Agency (EMA)
Head of IT, Austrian Medicines and Medical Devices Agency (AGES MEA)
Georg NeuwirtherHead of IT, Austrian Medicines and Medical Devices Agency (AGES MEA)
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
Director Regulatory Affairs EMEA Affiliates, Mylan
Kevin AireyDirector Regulatory Affairs EMEA Affiliates, Mylan
TEVA
Britt VermeijTEVA
Head Business Process & Excellence Information Management & Systems, Global Regulatory Affairs, Sandoz
Katarina NedogHead Business Process & Excellence Information Management & Systems, Global Regulatory Affairs, Sandoz
Policy & Advocacy Officer of the European Association of Hospital Pharmacist (EAHP)
Stephanie KohlPolicy & Advocacy Officer of the European Association of Hospital Pharmacist (EAHP)
Chairman, Dutch Skin Patients Organization (Huidpatiënten Nederland)
Ellen SwanbornChairman, Dutch Skin Patients Organization (Huidpatiënten Nederland)
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)
Technical Officer, World Health Organization (WHO)
Dr. Luther GwazaTechnical Officer, World Health Organization (WHO)
Associate Director, Iperion Life Sciences Consulting
Remco MunnikAssociate Director, Iperion Life Sciences Consulting
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
Head Regulatory Information Management, Global Regulatory Affairs, Teva
Stuart IzodHead Regulatory Information Management, Global Regulatory Affairs, Teva
Chair of the CMDh, AEMPS (ES)
Laura Oliveira SantamariaChair of the CMDh, AEMPS (ES)
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)
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)
HALMED (HR)
Sabina UzeirbegovićHALMED (HR)
See highlights from our 2019 event
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.
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CONFERENCE SPONSOR
Medicines for Europe is honored to be collaborating with the following partners to make this year’s conference
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