Free Live Online Masterclasses on RW Studies
Masterclass series centred on the practical theme of
‘How to ensure success of your RWE studies and avoid pitfalls’
Dates: Monthly starting in 2022 | Time: 5pm CET | 4pm UK | 11am EST | 8am PST
Programme
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 sessions will take place during 2022 and 2023 and will be delivered by leading native pharmacoepidemiologists together with OXON. They will be centred on understanding healthcare and data sources to fulfil RW field and secondary data studies, highlighting the changes and data sources as a result of the Covid-19 pandemic.
The series will include 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.
Calendar and Registration
The calendar below shows the upcoming masterclasses open for registration.
To register for a specific masterclass, use the appropriate link.
The number of attendees is limited to permit adequate discussion and feedback during the presentation and
| Title | Date | Start Time | Duration | Register |
|---|---|---|---|---|
| Real-World PV with OXON and SafeMed: Accelerating approval through real-time patient safety & drug monitoring
FREE LIVE WEBINAR DATE: Thursday, 26 February 2026 TIME: 5pm CET, 4pm BST, 11am EST, 8am PST DURATION: 1 hour and 30 minutes Traditional routes to marketing authorisation can be slow and may miss long-term real-world safety and effectiveness. Join this free live webinar to see how OXON-SafeMed delivers validated, real-time pharmacovigilance for innovative therapies, supporting early access and continuous monitoring in routine care beyond clinical trials. SPEAKERS Professor Thomas MacDonald MBChB MD FRCP Emeritus Professor of Clinical Pharmacology, University of Dundee, and internationally recognised leader in pharmacovigilance and safety studies. Author of over 530 publications (H-index 73), with extensive experience advising regulators including EMA, MHRA and FDA on drug safety and post-authorisation evidence generation. Dr Nawab Qizilbash MBChB MRCP MSc DPhil Honorary Associate Professor in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine and formerly Honorary Consultant Physician, Oxford. Dr Qizilbash has led and advised on numerous real-world data collection and secondary data safety and effectiveness (PMS, PASS and PAES) studies in Europe and the USA. MAIN TOPICS: -Current challenges in regulatory approval and reimbursement -How real-time RWE pharmacovigilance supports regulatory approval -Advantages of hierarchical versus conventional composite endpoints -How real-time RWE studies support reimbursement decisions -How the OXON–SafeMed collaboration accelerates approval and reimbursement -SafeMed system demonstration -Q&A DETAILS: - We will be using GoToWebinar. - You can join our session by using a Mac, PC or a mobile device. | 26/2/2026 | 5:00pm CET | 1.5 hours | Register |