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Germany is within OXON's 2019/20 webinar series to help understand health care for conducting optimal observational studies. European and Asian pharmaco-epidemiologists and OXON field project managers experienced in Safety and Outcomes observational studies will make presentations and provide practical guidance based on their experience with drugs and vaccines. Date: July 3, 2019 at 5pm CET | 4pm UK | 11am EDT | 8am PST Agenda: Chair: Dr Nawab Qizilbash, Senior Clinical Epidemiologist, OXON and
Key Speaker: Dr Niklas Schmedt, Head of Health Services Research & Pharmacoepidemiology, InGef, Institute for Applied Health Research Berlin, Germany (60 minutes):
- Questions and Answers session (10-15 minutes) |
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The Nordics is within OXON's 2019/20 webinar series to help understand health care for conducting optimal observational studies. European and Asian pharmaco-epidemiologists and OXON field project managers experienced in Safety and Outcomes observational studies will make presentations and provide practical guidance based on their experience with drugs and vaccines. Date: June 5, 2019 at 5pm CET | 4pm UK | 11am EDT | 8am PST Agenda: Chair: Dr Nawab Qizilbash, Senior Clinical Epidemiologist, OXON and
Key Speaker: Professor Vera Ehrenstein, Department of Clinical Epidemiology, Aarhus University, Denmark (60 minutes):
- Questions and Answers session (10-15 minutes) |
REGISTER HERE |
Italy is the third of OXON's 2019/20 webinar series to help understand health care for conducting optimal observational studies. European and Asian pharmaco-epidemiologists and OXON field project managers experienced in Safety and Outcomes observational studies will make presentations and provide practical guidance based on their experience with drugs and vaccines. Date: May 16, 2019 at 5pm CET | 4pm UK | 11am EDT | 8am PST Agenda: Chair: Dr Nawab Qizilbash, Senior Clinical Epidemiologist, OXON and
Key Speaker: Carlo Giaquinto, Professor of Paediatrics and Chief Investigator of Pedianet, University of Padua. (60 minutes):
- Questions and Answers session (10-15 minutes) |
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UK is the second of OXON's 2019/20 webinar series to help understand health care for conducting optimal observational studies. European and Asian pharmaco-epidemiologists and OXON field project managers experienced in Safety and Outcomes observational studies will make presentations and provide practical guidance based on their experience with drugs and vaccines. If you are a pofessional in the biopharmaceutical or medical device industry involved in the production of real-world evidence, join Professor Nicholas Moore from University of Bordeaux to learn about health care system in France and get practical knowledge and advice to apply to your next field, secondary data or hybrid observational study. In 90 minutes, get practical knowledge and advice to apply to your next field, secondary data or hybrid observational study for safety, HEOR/market access, drug development and marketing. UK - APRIL 25, 2019 AT 5PM CET Key Speaker: Thomas MacDonald, Professor of Clinical Pharmacology and Pharmacoepidemiology in the Medical Research Institute, University of Dundee, and Honorary Consultant Physician at Ninewells Hospital and Medical School |
REGISTER HERE |
France is the first of OXON's 2019/20 webinar series to help understand health care for conducting optimal observational studies. European and Asian pharmaco-epidemiologists and OXON field project managers experienced in Safety and Outcomes observational studies will make presentations and provide practical guidance based on their experience with drugs and vaccines.If you are a pofessional in the biopharmaceutical or medical device industry involved in the production of real-world evidence, join Professor Nicholas Moore from University of Bordeaux to learn about health care system in France and get practical knowledge and advice to apply to your next field, secondary data or hybrid observational study. In 90 minutes, get practical knowledge and advice to apply to your next field, secondary data or hybrid observational study for safety, HEOR/market access, drug development and marketing. FRANCE - MARCH 13, 2019 AT 5PM CET Key Speaker: Nicholas Moore Agenda: Chair: Dr Nawab Qizilbash, Senior Clinical Epidemiologist, OXON and Honorary Associate Professor, London School of Hygiene & Tropical Medicine: Speakers: Prof Nicholas Moore, Head of Pharmacoepidemiology, University of Bordeaux. (60 minutes): - Key demographic profile relevant to healthcare Rosario Fernandez-Arruti (Field Project Manager at OXON): Questions session (10-15 minutes) |
Register now! |
European HEALTHCARE for PHARMACOEPIDEMIOLOGY and RISK MINIMISATION Studies
4th Annual 3-day Course
15th - 17th March 2016
The Royal Society of Medicine, London
An understanding of the health care system and how medicine is practiced is essential to the design and planning of successful pharmacoepidemiological (PE) and risk minimisation (RM) studies. The course focuses on acquiring this practical knowledge and applying it to PE and RM studies in different therapeutic areas.
Learn from national academic and regulatory experts:
Prof. Nicholas Moore, Prof. Edeltraut Garbe, Prof. Carlo Giaquinto, Prof. Tom Macdonald, Dr. Nawab Qizilbash, Prof. Ulf Bergman, Dr. Vera Ehrenstein, Prof. Miriam Sturkenboom, Prof. Helen Dolk, Dr. Diego Macias, Dr. Annalisa Rubino, Andrew Maguire, Dr. Gema Requena, Dr. Lorenzo Dominguez
Half Day for each ´Big 5´ country and, collectively, ´Small 5´ countries:
Part I: Understanding Health Care for Observational Studies
Part II: Secondary Data Studies
Part III: Field Studies (including patient registries, retrospective chart reviews and surveys)
Part IV: Practical - Designing and planning a pharmacoepidemiological study
And
Responses from delegates asked if they would recommend the course to colleagues:
Register now! |
IMPLEMENTATION AND EVALUATION OF RISK MINIMISATION IN EUROPE
3rd Annual One-DAY PRACTICAL WORKSHOP
18th March 2016
The Royal Society of Medicine, London
An understanding of risk minimisation is now key to the successful introduction and maintenance of drugs on the market.
This master class focuses on acquiring and applying the practical regulatory, scientific and logistical aspects of additional risk minimisation measures and their evaluation in the EU. I. Theoretical approach and working framework for risk minimisation
II. Regulatory background
III. Available tools and guidance at the EU levelI
V. Practical approach to the selection and development of additional risk minimisation measures — pre and post approval
VI. Practical approach to the evaluation of the effectiveness of additional risk minimisation measures
VII. Review of the results of additional risk minimisation measuresVII. Challenges & ways forward: How regulators may react to various additional risk minimisation measures and studies—hypothetical scenarios
Speakers
Responses from delegates asked if they would recommend the WORKSHOP to colleagues:
“An excellent opportunity to candidly share practical experiences with the new GVP guidance on risk minimisation and PASS studies in a small group environment with relevant stakeholders” Director, Medical Surveillance and Coding, Gilead
"Experts from academia and health authorities presenting and attending colleagues from other firms in a small group facilitated open discussion, true expert input and helped significantly in the understanding of the legislation/guidelines as well as the implementation challenges at industry side.” “This workshop was a "win-win-win" for the experts from academia, the regulators and the industry attendees." Associate Head Mature Products, Safety Science, Roche
3rd Annual 3-day Course:
European HEALTHCARE for PHARMACOEPIDEMIOLOGY and RISK MINIMISATION Studies
25th - 27th March 2015
The Royal Society of Medicine, London
An understanding of the health care system and how medicine is practiced is essential to the design and planning of successful pharmacoepidemiological (PE) and risk minimisation (RM) studies.
The course focuses on acquiring this practical knowledge and applying it to PE and RM studies in different therapeutic areas.
Learn from national academic and regulatory experts:
Prof. Nicholas Moore, Prof. Edeltraut Garbe, Prof. Carlo Giaquinto, Prof. Tom Macdonald, Dr. Nawab Qizilbash, Prof. Ulf Bergman, Dr. Vera Ehrenstein, Prof. Miriam Sturkenboom, Prof. Helen Dolk, Dr. Diego Macias (Spanish Medicines Agency), Dr. Sabine Straus (PRAC member)
Half Day for each ´Big 5´ country and, collectively, ´Small 5´ countries:
Part I: Understanding Health Care for Observational Studies
Part II: Secondary Data Studies
Part III: Field Studies (including patient registries, retrospective chart reviews and surveys)
Part IV: Practical - Designing and planning a pharmacoepidemiological study
And EU multi-country pharmacoepidemiological database studies, EU Risk Minimisation studies & EU multi-country pregnancy registries
Responses from delegates asked if they would recommend the course to colleagues:
RISK MINIMISATION: Implementation and Evaluation of EU studies
2nd One-DAY PRACTICAL WORKSHOP
24th March 2015
The Royal Society of Medicine, London
An understanding of risk minimisation is now key to the successful introduction and maintenance of drugs on the market.
This master class focuses on acquiring and applying the practical regulatory, scientific and logistical aspects of additional risk minimisation measures and their evaluation in the EU.
I. Theoretical approach and working framework for risk minimisation
II. Regulatory background
III. Available tools and guidance at the EU level
IV. Practical approach to the selection and development of additional risk minimisation measures — pre and post approval
V. Practical approach to the evaluation of the effectiveness of additional risk minimisation measures
VI. Review of the results of additional risk minimisation measures
VII. Challenges & ways forward: How regulators may react to various additional risk minimisation measures and studies—hypothetical scenarios
Speakers
Responses from delegates asked if they would recommend the course to colleagues:
“An excellent opportunity to candidly share practical experiences with the new GVP guidance on risk minimisation and PASS studies in a small group environment with relevant stakeholders” Director, Medical Surveillance and Coding, Gilead
"Experts from academia and health authorities presenting and attending colleagues from other firms in a small group facilitated open discussion, true expert input and helped significantly in the understanding of the legislation/guidelines as well as the implementation challenges at industry side.” “This workshop was a "win-win-win" for the experts from academia, the regulators and the industry attendees." Associate Head Mature Products, Safety Science, Roche
Hear OXON (a preferred provider of EU PASS/risk minimisation studies to several big pharma) the Annual conference in Pharmacovigilance in Berlin in February
Join to discuss the latest regulatory frameworks for pharmacovigilance in Europe!
An update on the implementation of the new pharmacovigilance legislation with a particular emphasis on the regulatory aspects.
New features of the pharmacovigilance legislation and their impact on regulatory activities
New pharmacovigilance legislation and how it is impacting drug development
Drug Safety Management across a product`s lifecycle
Risk managemant and Monitoring Effectiveness of Risk Minimalisation
Latest Innovation and Trends in Drug Safety
Big data &Pharmacovigilance
Panel discussion on impact on drug development and approval
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