Immunogenicity and Biosimilarity

Immunogenicity and Biosimilarity

Annual Biopharmaceuticals Meeting 2013 - Thomas Schreitmüller
Description: 24 Minutes

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Regulatory institutions and other stakeholders of the European system of pharmaceuticals, their functions and role

Seminar 1: European Pharmaceutical Regulatory Environment - Judith Creba/Genevieve Le Visage/Silvia Pfaff


Introduction
Role of the Parliament, Council, EU Commission, DG SANCO
Working effectively with the EMA
o Legal basis, role, structure and procedures
o Executive Director
o Management Board
o Secretariat: EMA’s support of the authorization process of medicinal products
o Involvement of external experts
o QRD product information, invented name requests
o Transparency, communication and publications
o European Public Assessment Report (EPAR)
o Annual Report
EMA Scientific Committees, their interaction and their working parties
o CHMP, PRAC, COMP, PDCO, CAT
o Expert committees SAG
The national agencies of the EU/EEA member states
The HoA network
The Industry trade associations
Involvement of patient organisations

Length: 197 min
412.00
plus 19% VAT
Access time 2 day(s)
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The Speakers:

Judith Creba has a PhD in Biochemistry from Birmingham University in the UK and spent 5 years working in Research in the Pharma Industry in the areas of Neuroscience, Pain, Cardiovascular and Metabolism. Judith has many years of experience in Regulatory Affairs and drug development in Novartis - working in different areas such as Oncology and Infectious Diseases, where she was involved in the development and approval of an antimalarial drug, and as the EU Regulatory Head of the Cardiovascular and Metabolism Group where she was involved in the successful development, approval and life cycle management of some key products of Novartis. Judith is now Head of EU Liaison and Policy in Drug Regulatory Affairs at Novartis where she is involved in Health Authority Liaison and also represents Novartis in various working groups in Industry Trade Associations such as EFPIA.
 

Dr. Silvia Pfaff is Global Head Regulatory Excellence in Drug Regulatory Affairs at Novartis in Basle, Switzerland.

She joined Novartis in July 2007 as EU Regional Head for the Business Franchise Immunology and Infectious Diseases and then took on global responsibility as Global Therapeutic Area Lead for Immunology and Bone.

Prior to joining Novartis she was Director, Therapeutic Area Immunology, at Abbott Laboratories and Knoll AG in Ludwigshafen, Germany.

She has got more than 20 years of regulatory experience in positions with increasing responsibility at Sanofi, Boehringer Mannheim, Knoll, Abbott and Novartis with a focus on biologics over the past 15 years.

She has a proven track record of successful submissions of global products in Europe, the US and Japan and achieving approvals with highly competitive labels.

Dr. Pfaff trained as pharmacist at the University of Heidelberg and earned her Ph.D from the Technical University in Munich.


Dr Geneviève Le Visage is currently heading the EU Regulatory Intelligence & Policy group at Novartis Pharma AG in Basel. Prior to this, she worked for ten years at the European Medicines Agency in London, mainly in the Medical Information sector, where she set up the processes for the publication of public-friendly documents, such as question-and-answer documents designed to explain the rationale for the Agency’s decision on new medicines approvals or on safety reviews. This included defining the standards for the documents, as well as training and managing the medical writing team. She also coordinated all EMA’s activities regarding European Public Assessment Reports (standard operating procedures, monitoring activities, support to internal and external users of EPARs, development of the product and EPAR pages of the EMA website). Prior to joining the EMA, she worked for GlaxoSmithKline in West London in the field of prescribing information. Dr Le Visage is a pharmacist, having graduated from Nantes University (France) and also holds a masters in Science Communication from Imperial College, London (UK).


More information on the seminar.