Addressing Regulatory Requirements in Medical Device and Drug Development
Date: Tuesday, 15 June, 2010
Time: 9:00 – 12:45
Location: The Israel Export & Int'l Cooperation Institute,
29 Hamered, Tel Aviv, 5th floor, Israel Conference Room
Language: English
Registration Fee: FREE!!
Lecturers:
Ron Nash
Medical Technical Manager
Intertek Amtac Certification Services
Larry Bowhill
Business Development Manager
Intertek Pharmaceutical Services
Mary P Ryan
Operations Manager & Director for EMEA
Intertek Systems Certification
Stephen Levenstein, MD
MD VP Research Division
GCP Clinical Studies
Tse'ela Schwartz
Medical Devices Clinical Research Manager
GCP Clinical Studies
The Israel Export & International Cooperation Institute and LSA – Life Science Accelerator Ltd are happy to invite you to a morning educational seminar by leading international experts in the fields of regulatory, certification, analytical solutions and clinical studies.
This seminar is addressed to drug and medical device company professionals involved in the R&D, regulatory affairs and clinical studies:
- Executives of medical device and bio/pharma companies
- R&D managers and personnel
- Analytical scientists
- QA managers and personnel
- Clinical Project Managers
- Regulatory affairs
- Medical affairs
Free Registration!
Limited number of participants.
Program Agenda
| Topic | Speaker | Time |
|---|---|---|
| Registration | 9:00 – 9:30 | |
| Welcoming Words | Mr. Ronen Gruber Mr. Yossi Bornstein | 9:30 – 9:45 |
| Clinical Evaluation for Medical Device Claims Through the Literature Route: Implications of the MDD 2007/47/EC amendment for Manufacturers | Mr. Ron Nash Intertek Systems Certification | 9:45 – 10:40 |
| Break and refreshments | 10:40 – 10:55 | |
| How to Conduct Successful Clinical Studies in Devices and Drugs: The Importance of Early Planning | Dr. Stephen Levenstein and Ms. Tse'ela Schwartz GCP Clinical Studies | 10:55 – 11:50 |
| Regulatory Changes Affecting Biopharma / Pharma Drug Development and Manufacture | Mr. Larry Bowhill Intertek Pharmaceutical Services | 11:50 – 12:45 |
| Networking and One-on-One Meetings | 12:45 - |
About the Lecturers:
Ron Nash, Medical Technical Manager at Intertek Amtac Certification Services, has an admirable industrial career in Quality Management/Assurance for over 40 years.
Ron held esteemed positions as Lead Auditor and Specialist within Amtac since 1978 prior to his promotion as Medical Technical Manager and Certification Authority in 2004.
Ron joined the ‘Specialized Medical Device arena’ in 1992 when he was sub contracted from Amtac to work with the Medical Devices Directorate (precursor to Medical Devices Agency and subsequently now known as 'MHRA', the Medicines and Healthcare products Regulatory Agency, approving medical device manufacturers globally for selling products into UK).
Mary P Ryan started within quality management systems for health service providers and local councils in 1993 and thereafter diversifying into sub-contract electronics and medical device manufacturing until 2007 when she joined Intertek Systems Certification as Operations Manager & Director for EMEA.
Larry Bowhill is an analytical scientist with more than 35 years experience in the pharmaceutical and fine chemical industries. As Business Development manager for Intertek Pharmaceutical Services he collaborates with companies at various stages of development, from university spin-outs to major Pharma organizations helping identify analytical solutions to regulatory issues that can range from process validations through to complex biopharmaceutical comparability studies.
Stephen Levenstein, MD, manages the research division of GCP Clinical Studies. He has over 16 years experience in the pharmaceutical industry and clinical research. He previously served as Medical Director for Bristol-Myers Squibb in both South Africa and Israel with responsibility for both research and regulatory affairs. Dr Levenstein has extensive experience in all phases of clinical research from protocol development to final study report.
Tse'ela Schwartz is the Medical Devices Clinical Research Manager of GCP Clinical Studies. She has over 10 years experience as a statistician and clinical research manager. She previously served as manager of clinical research in the Clinical Department of Sunlight Medical Ltd.
About Intertek:
Intertek is an industry leader in testing, inspection and certification with more than 25,000 people in 1,000 locations in over 100 countries. Whether your business is local or global, we ensure products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world. We hold extensive global accreditations, recognitions, and agreements, and our knowledge of and expertise in overcoming regulatory, market, and supply chain hurdles is unrivalled.
Intertek Amtac Certification Services have been serving a large number of Medical Device companies in Israel for the last 14 years for CE Certification and quality management systems auditing, enabling clients to sell their products on a global platform.
Visit our website at www.intertek.com
About GCP Clinical Studies:
GCP Clinical Studies Ltd. is a leading full service CRO and provider of educational programs in Israel. Our clients range from startups to major international organizations.
Visit our website at www.gcp.co.il
About LSA:
LSA - Life Science Accelerator Ltd., a subsidiary of Shizim Group, provides a wide umbrella of developmental, clinical and business services that are required along the life cycle of a biomed company. LSA represents leading international service providers in Israel in each required professional service category, and takes an active role in business mentoring of life-science companies.
Visit our website at www.LSAhome.com
Registration is FREE. Number of participants is limited!
SECURE PARTICIPATION – CALL IMMEDIATELY FOR PRE-REGISTRATION!
For registering please click here.
For further information, registration and one on one meeting booking please contact:
Yuval Almougy, Business Development Manager
LSA – Life Science Accelerator
Tel: 972-3-9002000 | Email: yuval@shizim.com
Ronen Gruber, Business Development Manager - Biotech, Pharmaceuticals & Nanotech Industries
The Israel Export & International Cooperation Institute
Tel: 972-3-5142938 | Email: roneng@export.gov.il