Pre- International Conference of Drug Regulatory Authorities (ICDRA)

24 - 25 August 2014 Sofitel Rio de Janeiro

24 - 25 August 2014


08:00 to 17:30


Sofitel Rio de Janeiro


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As government officials and drug regulatory authorities meet in Rio de Janeiro on the 26th-29th August for the 16th International Conference of Drug Regulatory Authorities (ICDRA), a pre-conference entitled “Ensuring Quality and Safety of Biosimilars for Patients Worldwide” will take place 24-25 August 2014. More than 400 experts from drug regulators, academia, non-governmental organizations and international organizations through to the pharmaceutical industry will be in attendance. Experts from IFPMA’s Biotherapeutics Group will be actively involved as speakers on important issues including regulatory challenges; the way forward for different types of biotherapeutic products; how to accelerate access; ensuring safety through pharmacovigilance; and whether similar biotherapeutic products should have or share the same International Non-Proprietary Name (INN) as originator biotherapeutics.


08:00 - 09:00


09:00 - 10:30

Plenary 1 – Regulatory challenges of biotechnological products

11:00 - 12:30

Plenary 2 – Regulatory framework for similar biotherapeutic products (SBPs): challenges and way forward

14:00 - 15:30

Workshop 1 – Regulatory experience: China , Workshop 2 – Pharmacovigilance for biotherapeutic products

16:00 - 17:30

Workshop 3 – Nommenclature, Workshop 4 – Regulatory experiences: Brazilian experience,

18:00 - 20:00

Pre-ICDRA Welcome Reception

09:00 - 10:30

Workshop 5 – Ensure the quality of SBPs throughout standardization, Workshop 6 – WHO Guidelines on SBPs

11:00 - 12:30

Workshop 7- Immunogenecity in biotherapeutics/SBPs , Workshop 8 – EU Regulatory framework and experience

14:00 - 15:30

Workshop 9 – Clinical comparability , Workshop 10 – Regulatory experience: Republic of Korea

16:00 - 17:30

Plenary 3 – Access to medicines and the impact of biosimilars on markets


Dr. Virginia Acha Director, International Regulatory Policy, Amgen

Dr. Virginia Acha has worked in private sector and academia throughout her career, combining her interests in science policy research and performance within and across organizations. She joined Amgen at the start of 2013 to support the company in R&D policy development and regulatory affairs on a number of issues, including specifically biosimilars and pharmacovigilance for biologics for Europe, the Middle East and Africa. She holds the chair for the Pharmacovigilance working group in the IFPMA Biotherapeutics Committee, the Vice-Chair for the EBE Biosimilars Task Force and the lead for the EFPIA Regulatory Network supporting Turkey.
Previously, Virginia spent nearly 5 years at Pfizer working on policy development and engagement in a number of domains, including science, innovation and access and choice in healthcare. In this role, she undertook analysis and policy development in key areas of the business including biosimilars, the value of innovation, personalised medicine and healthcare markets and procurement methods.
Virginia joined Pfizer in early 2008, after a decade in academia where she held posts on innovation strategy at Imperial College London Business School, the Science Policy Research Unit (SPRU) at the University of Sussex, the Centre for Research in Innovation Management (CENTRIM) at the University of Brighton, as well as a post-doctoral fellowship at London Business School. She has a Dphil in Science and Technology Policy Studies from SPRU.

Dr. Thomas Schreitmueller Head of Technical Regulatory Policy & Strategy Biologics F. Hoffmann-La Roche Ltd Dr.

Dr. Thomas Schreitmueller holds a Diploma and PhD in Biochemistry from the University of Munich (Max Planck Institute for Biochemistry, Munich, Martinsried and Institute for Clinical Chemistry and Clinical Biochemistry University of Munich). In 1989 he joined Roche holding various positions in the biotech area (e.g. Analytical R&D, technical project management).
Since 2003 Thomas was heading the department “Analytical R&D and Quality Control Biotech Products” at Roche Pharma Technical Operations in Basel, Switzerland. The department assumed responsibility for basic analytical research in the context of biotech products, was doing the analytical development and quality control of biotech development products and clinical supplies respectively, and was responsible for the quality control of Roche marketed biotech products (e.g. Roferon-A, Neupogen, Zenapax, Herceptin, Mabthera, Pegasys, Avastin…) manufactured at Roche Basel.
Since 2010 Thomas is the global lead for regulatory policy for biologics within Roche leading and coordinating the development of Roche positions on regulatory policy topics related to biotheapeutic and similar biotherapeutic products.

Jay P. Siegel MD, Chief Biotechnology Officer and Head of Scientific Strategy and Policy Johnson & Johnson

Dr. Jay Siegel is Chief Biotechnology Officer and Head of Scientific Strategy and Policy for Johnson & Johnson. In these roles, he is actively engaged in R&D leadership and in policy development at the national and international levels with regard to scientific and regulatory issues. He currently serves on the Executive Committees and the Boards of Directors of the Biotechnology Industry Organization and the Alliance for Regenerative Medicine.
Dr. Siegel joined Johnson & Johnson in 2003 as President of Centocor Research & Development, Inc., and subsequently served as Group President of R&D with oversight of research and development in Biotechnology, Immunology and Oncology. Dr. Siegel later served as Head of Global Regulatory Affairs for Janssen, the pharmaceutical companies of Johnson & Johnson, and led the company’s Biotechnology Center of Excellence.
Before joining Johnson & Johnson, Dr. Siegel spent 20 years at the FDA Center for Biologics Evaluation & Research in positions of increasing responsibility regulating the biotechnology industry.
Dr. Siegel received a B.S. in Biology from the California Institute of Technology and an M.D. from Stanford University. He trained in Internal Medicine at the University of California, San Francisco, and in Infectious Diseases and Immunology at Stanford University. Dr. Siegel is recipient of numerous honors including the U.S. Public Health Service’s highest honor, the Distinguished Service Medal and, twice, the HHS Secretary’s Award for Distinguished Service. He has been elected to fellowship in the American College of Physicians and the Society for Clinical Trials and has authored numerous publications in the areas of clinical trial design, biotechnology, immunology, and drug development policy.

Janis Bernat Association Director, Biotherapeutics & Scientific Affairs, IFPMA

Ms. Janis Bernat joined IFPMA in 2006 and began her career there working on the vaccines and influenza portfolios. She is now responsible for the organization’s activities in the area of biotherapeutic medicines, including biosimilars, and scientific affairs. She works with IFPMA members to develop policy and advocacy initiatives aimed at improving global health and strengthening medicines regulation. Prior to joining IFPMA, she worked for a US-based multi-national food company in quality assurance and regulatory compliance. She holds degrees in both agriculture and mass communications.

Caroline Mendy Manager, Regulatory Policy, IFPMA

Ms. Caroline Mendy joined IFPMA in 2012 from the World Health Organization (WHO), where she held the position of Technical Officer in the Essential Medicines and Pharmaceutical Policies department (EMP), focusing on technical support to WHO Member States on quality control/assurance (QC/QA) of pharmaceutical products, and providing the Secretariat of the WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Prior to WHO, Caroline worked at the Council of Europe, European Directorate for the Quality of Medicines and Healthcare (EDQM) in Strasbourg (France) as Scientific Administrator, focusing on the drafting and revision of European Pharmacopoeia (Ph.Eur) texts; and for 2 years at Pharmascience Inc. in Montreal (Canada) as Specifications and Drug Master Files (DMFs) Specialist. Caroline holds an M.Sc. in Biochemistry from the University of Paris VII (France), and an M.Sc. in Pharmaceutical Sciences – Drug Development from the Faculty of Pharmacy of University of Montreal (Canada).