Courses & resources
JOIN OUR WEBINAR ON HEALTH CARE AND OBSERVATIONAL STUDIES IN GERMANY
LIVE WEBINAR, July 3, 2019
JOIN OXON'S 2019/20 FREE KEYNOTE WEBINAR SERIES
Understanding Health Care for Field and Secondary Data Observational Studies in Germany
July 3, 2019 | Time: 5pm CET | 4pm UK | 11am EST | 8am PST
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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
Honorary Associate Professor, London School of Hygiene and Tropical Medicine:
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- Welcome and introductions (5 minutes)
Key Speaker: Dr Niklas Schmedt, Head of Health Services Research & Pharmacoepidemiology, InGef, Institute for Applied Health Research Berlin, Germany (60 minutes):
- Demographic profile relevant to health care in Germany
- Brief relevant structure of the healthcare system
- General patient clinical management patterns
- Databases: strengths and challenges
- Questions and Answers session (10-15 minutes)
View all webinar series programme
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JOIN OUR WEBINAR ON HEALTH CARE AND OBSERVATIONAL STUDIES IN THE NORDICS
LIVE WEBINAR, June 5, 2019
JOIN OXON'S 2019/20 FREE KEYNOTE WEBINAR SERIES
Understanding Health Care for Field and Secondary Data Observational Studies in the Nordics
June 5, 2019 | Time: 5pm CET | 4pm UK | 11am EST | 8am PST
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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
Honorary Associate Professor, London School of Hygiene and Tropical Medicine:
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- Welcome and introductions (5 minutes)
Key Speaker: Professor Vera Ehrenstein, Department of Clinical Epidemiology, Aarhus University, Denmark (60 minutes):
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- Learn about the Nordic Health Care and how this framework determinesobservational studies.
- Understand the patient clinical management patterns, for common and rare diseases, cancer and children
- Discover the key strengths and challenges of nordic Databases
- Questions and Answers session (10-15 minutes)
View all webinar series programme
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JOIN OUR WEBINAR ON HEALTH CARE AND OBSERVATIONAL STUDIES IN ITALY
LIVE WEBINAR, May 16, 2019
JOIN OXON'S 2019/20 FREE KEYNOTE WEBINAR SERIES
Understanding Health Care for Field and Secondary Data Observational Studies in Italy
May 16, 2019 | Time: 5pm CET | 4pm UK | 11am EST | 8am PST
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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
Honorary Associate Professor, London School of Hygiene and Tropical Medicine:
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- Welcome and introductions (5 minutes)
Key Speaker: Carlo Giaquinto, Professor of Paediatrics and Chief Investigator of Pedianet, University of Padua. (60 minutes):
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- Demographic profile relevant to health care in Italy
- Brief relevant structure of health care
- General patient clinical management patterns, for common and rare diseases, cancer and children
- Databases: strengths and challenges
- Questions and Answers session (10-15 minutes)
View all webinar series programme
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JOIN OUR WEBINAR ON HEALTH CARE AND OBSERVATIONAL STUDIES IN THE UK
LIVE WEBINAR , April 25, 2019
JOIN OXON'S 2019/20 FREE KEYNOTE WEBINAR SERIES
Understanding Health Care for Field and Secondary Data Observational Studies in UK
April 252019 | Time: 5pm CET | 4pm UK | 11am EST | 8am PST
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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
View all webinar series programme
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JOIN OUR WEBINAR ON HEALTH CARE AND OBSERVATIONAL STUDIES IN FRANCE
LIVE WEBINAR, MARCH 13, 2019
JOIN OXON'S 2019/20 FREE KEYNOTE WEBINAR SERIES
Understanding Health Care for Field and Secondary Data Observational Studies in FRANCE
March 13 2019 | Time: 5pm CET | 4pm UK | 11am EST | 8am PST
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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
Professor of Pharmacoepidemiology, University of Bordeaux
Agenda:
Chair: Dr Nawab Qizilbash, Senior Clinical Epidemiologist, OXON and
Honorary Associate Professor, London School of Hygiene & Tropical Medicine:
- Welcome and introductions (5 minutes)
Speakers:
Prof Nicholas Moore, Head of Pharmacoepidemiology, University of Bordeaux. (60 minutes):
- Key demographic profile relevant to healthcare
- Structure of health care
- Clinical practice patterns
- Data sources: strengths and challenges
- Examples
Rosario Fernandez-Arruti (Field Project Manager at OXON):
- Challenges for field studies and use of innovative methodologies (10-15 minutes)
Questions session (10-15 minutes)
MORE INFORMATION
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4th Course in European Healthcare for Pharmacoepidemiology and Risk Minimisation Studies
The Royal Society of Medicine, London, 15th - 17th March 2016
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
- 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:
- “Would recommend to colleagues at epi and safety department. Yes, good overview of the various health systems in EU and understanding of limitations to perform observational studies in EU”, Head Safety Evaluation and Risk Management, GSK Vaccines
- “Excellent overview of EU systems/ opportunities for studies. Acquired knowledge seems applicable (i.e. not too theoretical). Networking, high level of expertise of faculty”, Director, Epidemiologist, GSK Vaccines
- “Absolutely…Good exchange with teachers and among trainees. Very positive. Enjoyed a lot” Epidemiologist, Sanofi-Aventis Research and Development
- “Yes. First time that all different health care systems may be reviewed for so many countries” Risk Manager Officer / RMC Center of Excellence, Sanofi –Aventis
- “Yes, good overview, and right level of detail on some of the databases”, Head of Global HEOR, Novartis
- “Yes, very useful background of systems, structure and data sources”, Associate Director, Global Epidemiology and Observational Research, Takeda
- “Very useful to have in only 3 days an overview of different case systems where you can easily compare and confront differences and similarities”, Epidemiology Research Manager, Lundbeck SAS
3rd Annual Workshop: Implementation and Evaluation of Risk Minimisation in Europe
The Royal Society of Medicine, London, 18th March 2016
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
- Dr. Sabine Straus, Medicines Evaluation Board, the Netherlands. PRAC member and Rapporteur of the GVP Module XVI on risk minimisation.
- Dr. Annalisa Rubino, Director of Risk Management Epidemiology, OXON. Former Member of the EMA Risk Management team (2010—2015) and Rapporteur of GVP Module XVI on Risk Minimisation.
- Prof. Jeffrey Aronson, Reader in Clinical Pharmacology and Honorary Consultant Physician, Oxford University. Advisory Board of British National Formulary; Editor of Oxford Handbook of Practical Drug Therapy; Editor of Stephens’ Detection and Evaluation of Adverse Drug Reactions: Principles and Practice. Member of Technology Appraisal Committee of NICE.
- Dr. Lesley Wise, Vice President of Global PV Risk Management and Pharmacoepidemiology, Takeda (London).
- Dr. Rachel Sobel, Senior Director and a Group Lead for Global Innovative Pharmaceuticals for Epidemiology, Pfizer (New York).
- Dr. Nawab Qizilbash, Epidemiologist and Geriatrician, OXON and London School of Hygiene and Tropical Medicine, London.
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 Course in European Healthcare for Pharmacoepidemiology and Risk Minimisation Studies
The Royal Society of Medicine, London, 25th - 27th March 2015
Register Now!
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:
- “Would recommend to colleagues at epi and safety department. Yes, good overview of the various health systems in EU and understanding of limitations to perform observational studies in EU”, Head Safety Evaluation and Risk Management, GSK Vaccines
- “Excellent overview of EU systems/ opportunities for studies. Acquired knowledge seems applicable (i.e. not too theoretical). Networking, high level of expertise of faculty”, Director, Epidemiologist, GSK Vaccines
- “Absolutely…Good exchange with teachers and among trainees. Very positive. Enjoyed a lot” Epidemiologist, Sanofi-Aventis Research and Development
- “Yes. First time that all different health care systems may be reviewed for so many countries” Risk Manager Officer / RMC Center of Excellence, Sanofi –Aventis
- “Yes, good overview, and right level of detail on some of the databases”, Head of Global HEOR, Novartis
- “Yes, very useful background of systems, structure and data sources”, Associate Director, Global Epidemiology and Observational Research, Takeda
- “Very useful to have in only 3 days an overview of different case systems where you can easily compare and confront differences and similarities”, Epidemiology Research Manager, Lundbeck SAS
2nd Annual Workshop on Risk Minimisation: Implementation & Evaluation of EU Studies
The Royal Society of Medicine, London, 24th March 2015
Register Now!
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
- Dr. Sabine Straus, Medicines Evaluation Board the Netherands. Dutch PRAC member. Member of the writing committee for GVP module XVI on risk minimisation
- Prof. Jeffrey Aronson, Reader in Clinical Pharmacology, Oxford University and Honorary Consultant Physician, John Radcliffe Hospital. Member of Technology Appraisal Committee of NICE; Former Chief Editor of the British Journal of Clinical Pharmacology
- Dr. Nawab Qizilbash, Epidemiologist and Geriatrician, OXON and London School of Hygiene and Tropical Medicine, London
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
Annual Pharmacovigilance & Risk Management Strategies Summit
Berlin, Germany, February 5th-6th, 2015
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!
Key Practical Learning Points of the Summit:
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An update on the implementation of the new pharmacovigilance legislation with a particular emphasis on the regulatory aspects.
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New features of the pharmacovigilance legislation and their impact on regulatory activities
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New pharmacovigilance legislation and how it is impacting drug development
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Drug Safety Management across a product`s lifecycle
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Risk managemant and Monitoring Effectiveness of Risk Minimalisation
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Latest Innovation and Trends in Drug Safety
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Big data &Pharmacovigilance
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Panel discussion on impact on drug development and approval
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