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OXON’s FREE LIVE ONLINE REAL WORLD MASTERCLASS SERIES 2022-2023

OXON Masterclasses

FREE LIVE REAL WORLD MASTERCLASS SERIES 2022-2023

‘How to ensure success and avoid pitfalls in Real World studies by Understanding Healthcare in Europe and Asia’

Dates: Monthly starting in February 2022 | Time: 5pm CET | 4pm UK | 11am EST | 8am PST

OXON is resuming the series of masterclasses on real world evidence starting in February 2022

This Masterclass series follows the successful Masterclasses in 2021on real-world studies and RCTs by OXON and the eminent statistician, Stuart Pocock, Professor of Medical Statistics, London School of Hygiene & Tropical Medicine (devised: ‘Pocock Stopping Rule’, ‘Win Ratio’. ‘Individualising benefit-risk’); extensive experience with EMA/FDA and data monitoring committees (including adaptive platform Covid-19 DISCOVERY trial); >500 publications (100+ NEJM/Lancets) mainly of trials and epidemiology.

The series provides practical knowledge and advice from national academic experts to apply to field, secondary data and hybrid observational studies for safety, HEOR/market access and clinical development. It is aimed at professionals in the biopharmaceutical and medical device industries, anywhere in the world, involved in the production of real-world evidence and conduct of observational studies in Europe and Asia.

UPCOMING MASTERCLASSES CALENDAR

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Free Live Masterclass Series on RW Studies. Session 5: Evaluation of Risk Minimization Measures OXON’s Free Live Real-World Masterclass Series
'Evaluation of Risk Minimization Measures'

Date: Wednesday, 22 June 2022 at 5pm CEST | 4pm BST | 11am EDT | 8am PST

An understanding of EU risk minimisation and evaluation studies from an Ex-PRAC member and case studies from a clinical epidemiologist who conducts such studies.

In 60 minutes, get practical knowledge and advice to apply to your next risk minimisation study.

Chair and co-speaker:
Dr Nawab Qizilbash
Senior Clinical Epidemiologist, OXON and Honorary Associate Professor, London School of Hygiene & Tropical Medicine:
- Welcome and introductions (5 minutes)

Key Speaker:
Prof. Antoine Pariente
Professor of Pharmacology, Pharmacoepidemiology and Pharmacovigilance at the University of Bordeaux (ex-PRAC member)

Agenda:
-Risk minimisation and recent GVP update
-Review of risk minimisation survey studies for European regulators: considerations, challenges and PRAC feedback
-Two case studies on how to remove risk minimisation measures
-Case study on how to dramatically improve response rates in surveys
-Q&A session

Details:
- We will be using GoToWebinar.
- You can join our session by using a Mac, PC or a mobile device.

Please start registering by entering your data.
22 Jun, 202217:00 CEST1 hour
Register
Free Live Masterclass Series on RW Studies. Session 6: How to Conduct Successful Post-Authorisation Safety Studies (PASS) OXON’s Free Live Real-World Masterclass Series
'How to Conduct Successful Post-Authorisation Safety Studies (PASS)'

Date: Wednesday, 13 July 2022 at 5pm CEST | 4pm BST | 11am EDT | 8am PST

Review of PASS studies for European regulators: considerations, challenges and PRAC feedback

In 60 minutes, get practical knowledge and advice to apply to your next risk minimisation study.

SPEAKER: Nawab Qizilbash MRCP(UK) MSc DPhil(Oxon)
Senior Clinical Epidemiologist, OXON
Hon. Associate Professor, London School of Hygiene and Tropical Medicine
Clinical Observer, Madrid and Formerly Hon. Consultant Physician, Oxford

DISCUSSANT: Stuart Pocock
Professor of Medical Statistics, London School of Hygiene and Tropical Medicine.
Co-authored more than 600 papers (100+ NEJM/Lancet, and STROBE guideline), experience with EMA/FDA and data monitoring (including Covid DISCOVERY adaptive platform trial) and devised: 'Pocock Stopping Rule', 'Win Ratio' and new method for 'Individualising Benefit Risk'

Agenda:
-How to remove regulatory burdens with good and innovative design
-How to remove regulatory burdens with detailed feasibility and argumentation
-Usefulness of blinded clinical adjudication
-How to reduce costs with hybrid studies
-Q&A session

Details:
- We will be using GoToWebinar.
- You can join our session by using a Mac, PC or a mobile device.

Please start registering by entering your data.
13 Jul, 202217:00 CEST1 hour
Register
Free Live Masterclass Series on RW Studies. Session 7: China, Biobanks for Precision Medicine OXON’s Free Live Real-World Masterclass Series
"Healthcare and RWE in China. Biobanks for precision medicine"

Date: Wednesday, 14 September 2022 at 5pm CEST | 4pm BST | 11am EDT | 8am PST

In 60 minutes, get an overall picture of practical issues in establishing, managing and using biobank studies for population and biomedical research. Learn about the basic principles of biobanking, the process behind the construction of a biobank and the infrastructures supporting the implementation of biobanking in scientific research to enable scientists from around the world to make many important discoveries relevant to drug target validation, risk prediction, disease prevention and treatment, benefiting populations worldwide.

CHAIR: Nawab Qizilbash MRCP(UK) MSc DPhil(Oxon)
Senior Clinical Epidemiologist, OXON
Hon. Associate Professor, London School of Hygiene and Tropical Medicine
Clinical Observer, Madrid and Formerly Hon. Consultant Physician, Oxford

KEY SPEAKER: Prof. Zhengming Chen
Richard Peto Chair of Epidemiology, University of Oxford and Honorary Professor of Peking Union Medical College and Fudan University in China.

Details:
- We will be using GoToWebinar.
- You can join our session by using a Mac, PC or a mobile device.

Please start registering by entering your data.
14 Sep, 202217:00 CEST1 hour
Register

About OXON’s Free Live Masterclass Series on RW Studies

These are masterclass sessions to understand the healthcare for RW studies, led by leading professors of pharmacoepidemiology in Europe and Asia, centred on the practical theme of  “How to ensure success of your RWE studies and avoid pitfalls”

The series will be delivered by leading native pharmacoepidemiologists together with OXON, and it will be centred on understanding healthcare and data sources to fulfil RW field and secondary data studies in their various countries.

The current series will highlight the changes and data sources as a result of the Covid-19 pandemic.

The series will have additional ad-hoc Masterclasses on specific topics, such as:

  • External Control Groups for Regulatory and HTA submissions
  • Hybrid Pregnancy Safety Studies: New Approach
  • Multi-country RW Data Collection Studies
  • Multi-country RW Secondary Data Studies
  • Evaluation of Risk Minimization Measures (with an ex-PRAC member)

We will involve Professor Stuart Pocock’s extensive experience of trials, epidemiology, data monitoring and EMA/FDA for several of these topics.

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