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This meeting is organised for all, who develop or authorise biopharmaceuticals; for companies, for agencies as well as scientist; for professionals, who would like to get the latest news about biopharmaceuticals; to meet colleagues to exchange ideas, share experiences and listen to talks covering topics of highest current interest and importance.


Participant benefits include:

  • Gain an insider view on the current issues relevant for development and approval of biopharmaceuticals in the EU
  • Learn about most recent information on diversity of current topics
  • Meet representatives of regulatory agencies
  • Meet colleagues from other companies from different regions
  • Enjoy the highly dynamic and interactive atmosphere
  • Enjoy the various opportunities to network


Companies, institutions

Abbott GmbH & CoKG

F.Hoffmann-La Roche Ltd.


AbbVie Deutschland GmbH & Co. KG Falk Pharma Pharma-Bio Consulting
AbbVie Ltd


Pharmaceutical Services Div. /Ministry of Health


FHR Consult PharmaLex GmbH
ADRES Finnish Medicines Agency Pietrek Associates
AGES – Austrian Agency for Health and Food Safety Geneuro SA PROBIOGEN AG
Alder Biopharmaceuticals Glenmark Pharmaceuticals Ltd. Promogen-MAB LLC
Alfred E. Tiefenbacher (GmbH & Co KG) Grifols Deutschland GmbH Protagen AG
Amgen Hammel Consulting Ltd Protagen Protein Services GmbH
AMS Advanced Medical Services GmbH Harlan Laboratories Ltd. Ratiopharm GmbH, Teva Group Member
apceth GmbH & Co. KG Hexal AG Regulix Ltd
Apexigen Inc. Hospira Roche Austria GmbH
APOGENIX GmbH Hunton & Williams Roche Diagnostics GmbH
ASPHALION , S.L. i.DRAS GmbH Roche Pharma AG
Astra Zeneca IABS Samsung Bioepis Co., Ltd.
Aurealis Pharma immatics biotechnologies GmbH Sandoz Biopharmaceuticals c/o Hexal AG
BASG - Bundesamt für Sicherheit im Gesundheitswesen Intas Pharmaceuticals Sandoz GmbH
Baxter Deutschland GmbH Japanese Foundation for Cancer Research Sanofi
Baxter Innovations Jenkins & Jenkins Ltd. Sanofi-Aventis
Bayer Pharma AG Kanzlei Lützeler Klümper Wachenhausen Segulah Consulting
Berlin-Brandenburg Center for Regenerative Therapies (BCRT) Charité Universitätsmedizin Keyrus Biopharma SGS M-Scan Ltd.
Biocon Kinesis Pharma B.V. Soldan Regulatory Consultancy (SRC)
Biogen Idec Ltd. LEO Pharma SPC GmbH
BioGenerix AG LEUKOCARE AG State Institute for Drug Control
BioGeneriX GmbH, Teva Group Member LFB Biotechnologies SuppreMol GmbH
BioGenes GmbH LMU Munich Swiss Biotech Association
Biopartners Manhattan BioPharm Consultants Swissmedic
Bioprocess Group, TheraMAB LLC Materia Medica Holding Synthon BV
Bioreg medac GmbH TEVA Pharmaceuticals
BioReliance Medicines and Healthcare Products Regulatory Agency TEVA
EU Regulatory Affairs
Biotest AG Merck KGaA The HST Consulting Network GmbH
Boehringer Ingelheim Pharma GmbH & Co. KG Merck Millipore The medical writing experts
Bristol-Myers Squibb GmbH & Co. KGaA  (BMS) Merck Serono TheraMAB LLC
BSL Bioservice Scientific Laboratories GmbH Merckle GmbH TRANSGENE S.A.
CBG-MEB Medicines Evaluation Board Merus TRION Pharma GmbH
Clinipace AG MHRA UCB Pharma S.A.
Clinipace GmbH MicroCoat Biotechnologie GmbH UCB, University of Limerick
Coriolis Pharma Research GmbH Micromet uniQure Biopharma B.V.
Covance MorphoSys AG Université Paris Sud, Faculté de Pharmacie
CRO, Advanced Medical Services GmbH MSD (Europe) Inc. University of Costa Rica
CROMSOURCE MT Promedt Consulting GmbH University of Munich
CSL Behring AG Mylan GmbH University of Regensburg
CSL Behring GmbH National Pharmaceutical Control Bureau Voisin Consulting Life Sciences
Daiichi Sankyo Europe GmbH NDA Regulatory Service GmbH Wachenhausen Rechtsanwälte
Danish Health
and Medicines Authority
Novartis Corp (M) SDN BHD Wacker Biotech GmbH
Diagnostics GmbH Novartis Pharma AG Xendo B.V
Dr. Falk Pharma GmbH Novartis Pharma GmbH Xendo Deutschland
Dr. Regenold GmbH Novo Nordisk A/S Xendo Pharma Services
Épée Services Ltd. Nycomed GmbH YES Pharmaceutical Development Services GmbH
EUROPEAN GENERIC MEDICINES ASSOCIATION Opsona Therapeutics Zentralstelle für Technologietransfer; Albert-Ludwig-Universität Freiburg
European Pharmaceutical Consultancy Associates Ltd PAREXEL Consulting
F.Hoffmann-La Roche AG PAREXEL International GmbH


Adjunct Professor Head of Biotechnology Unit Regulatory Affairs Associate
Associate Director Head of Business Development Protein Services Regulatory Affairs Compliance Manager
Business Development & Reg. Strategy Head of Clinical Development Hematology Regulatory Affairs Consultant
CAT Member Head of Clinical Development Immunology Regulatory Affairs Director, Biosimilars
CGO Head of Clinical Submission Management Regulatory Affairs Manager
Chair CTFG Head of CMC and Regulatory Affairs Regulatory Affairs Professional
Chairman Head of Department of International Medical Documentation Regulatory Affairs Site Head
Chief Business Officer Head of DRA CMC Regulatory CMC Manager
Chief Development Officer Head of Drug Regulatory Affairs Regulatory Consultant
Chief Executive Officer Head of EU Liaison and Policy in Drug Regulatory Affairs Regulatory Program Manager
Chief Medical Officer Head of Global Clinical Development and Medical Affairs Regulatory Scientist
Chief Scientific Officer Head of Global DRA CMC Research Director
CHMP Member Head of Global Regulatory Oncology EU I Risk Management Physician
Clinical Assessor Head of Non-Clinical Development Scientific Consultant
Clinical Project  Manager Head of Oncology & Pain Scientist
Clinical R&D Director Head of Preclinical & Medical Affairs Senior Clinical Manager
Clinical Research Medical Advisor Head of Pre-clinical Development Department Senior Consultant
Clinical/Regulatory Affairs Project Manager Head of Production Senior Consultant - Integrated Product Development
Consultant Head of Project Management Senior Consultant - Nonclinical Development
Counsel Head of RA Biosimilar Senior Consultant RA CMC
Deputy Director Head of Regulatory Affairs Senior Director
Deputy Head Quality/CMC Head of Regulatory Affairs Biosimilars Senior Director
Business Development & Licensing Europe
Deputy Head Section Monoclonal and Polyclonal Antibodies Head of Regulatory Affairs Group (HRM) Biopharmaceuticals Senior Director Regulatory Affairs Europe Biologics & Biopharmaceuticals
Deputy QPPV Head of Regulatory Biologics Senior Director Scientific Affairs
Director Head of Section Clinical Trials Senior Director, Head of Global Regulatory Oncology EU
Director (EU)
Head of Section Mono and Polyclonocal Antibodies Senior DRA Manager
Director BioService Head of Future Products Senior Expert in the Institute for Assessment and Analysis
Director Business Development IABS President Senior Expert Scientific & Regulatory Affairs
Director Clinical Development Immunologist Senior Global Programme Leader
Director Clinical Projects Int. Project Manager Senior Global Regulatory Manager Biologics
Director CRA Intelligence Regulatory Senior Manager
Director GRA CAC Junior Manager CRA International Senior Manager Medical
Director Quality Management Laboratory Head Senior Manager Regulatory Affairs
Director Regulatory Affairs Laboratory Head Bioanalytics Senior Manager Regulatory Affairs Critical Care Europe
Director Regulatory Affairs Germany, Austria and Switzerland Laboratory Manager Senior Manager Scientific Affairs Biopharmaceuticals
Director Regulatory Sciences Lawyer Senior Manager, Pre Clinical Affairs, Pharmacology and Toxicology
DRA-Manager Manager Global Regulatory Affairs-CMC Senior Medical Officer
Drug Regulatory Affairs, Teamlead Primary Care & Critical Care Manager IPD Senior Medical Writer und Medical Advisor
Dutch member in the Pharmacovigilance Risk Assessment Committee (PRAC) Manager Regulatory & Clinical Affairs Senior Principal Scientist
Executive Director Manager Regulatory Affairs Senior Programme Manager
Expert Medical Assessor Manager Regulatory Affairs CMC Senior Quality Assessor
Formerly EMA Manager Regulatory Affairs Antibody Therapy Europe Senior RA Manager Biosimilars
Formerly PMDA Manager Regulatory Sciences Senior Regulatory Affairs Manager
Founder Manager Technical Regulatory Senior Regulatory CMC Manager
General Manager - Regulatory Affairs Managing Consultant Senior Regulatory Expert
Global Clinical Development Manager Managing Director Senior Regulatory Intelligence Manager
Global Director, BioPharma Services Development Marketing/Sales Director Senior Regulatory Program Manager
Global Head ASPIRE Task Force Medical Director Senior Researcher
Global Head Regulatory Excellence Oncology OCD Senior Director Senior Scientist
Global OA Director PDRA, Pharmaceutical Assessor Senior Vice President, GB Medical / Regulatory Affairs
Global Program Regulatory Manager Pharmacology and Toxicology Senior VP, Senior Strategy Advisor - Oncology
Global Regulatory Affairs Pharmacovigilance Manager Specialist Technical Regulatory
Global Regulatory Affairs Biosimilars Physician Staff member of the MEB
Global Regulatory Franchise Head Preclinincal Assessor Techn. Project Leader
Global Regulatory Leader for Biosimilar President Technical Account Manager
Global Regulatory Oncology EU I President  Project Director VHP-Coordinator
Global Regulatory Strategist Profesor Catedrático   (Professor) Vice President
Head of  EU Liaison and Policy Professor Vice President Corporate Regulatory Affairs
Head of Analytical Charcterization Program Leader Vice President Global Head Biologics
Head of Bioassay Department Project Manager Vice President Pharma Development
Head of Biologics Safety & Disposition Quality Reviewer Vice President Regulatory Affairs
Head of Biosimilars Global Regulatory Affaris Regulatory Affairs - Inflammation & Growth Hormone Vice President, Head Regulatory Affairs, Biosimilars
Head of Biostatistics & Clinical Submission Management Regulatory Affairs Advisor


Austria Germany Russia
Belgium India Spain
Costa Rica Ireland Sweden
Czech Republic Israel Switzerland
Denmark Japan The Netherlands
Finland Korea United Kingdom
France Malaysia USA