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
| Title | Date | Start Time | Duration | Register |
|---|---|---|---|---|
| OXON's Free Live Webinar Series: Session 1 - Mastering RWE studies in South Korea
OXON’s Free Live Online Webinar Series on RWE 'Unlocking Success: Mastering RWE Studies in the Healthcare Landscapes of Asia and Europe' Session 1: Mastering RWE Studies in the Healthcare Landscape of South Korea Date: 09 May 2024 at 5pm CEST | 4pm BST | 11am EDT | 8am PST An understanding of the healthcare system in South Korea and how medicine is practised within its context. In 60 minutes, delve into the heart of healthcare systems and data sources in South Korea, empowering your proficiency in Real-World field, secondary data and hybrid studies with practical knowledge and advice to apply to your study for safety, HEOR/market access, drug development and marketing. Topics include: -Key demographic profile relevant to healthcare -Structure of healthcare -Clinical practice patterns -Data sources, their strengths and challenges -Strengths and challenges for field studies and use of innovative methodologies -Q&A session 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: Dr Ju Hwan Kim Research Assistant Professor of Pharmacoepidemiology and Pharmacovigilance, School of Pharmacy, Sungkyunkwan University, South Korea. Webinar ID 428-954-643 Details: - We will be using GoToWebinar. - You can join our session by using a Mac, PC or a mobile device. - You will receive a confirmation email. Use the link to join the session, or login at https://global.gotowebinar.com/join and enter the 9-digit Webinar ID and the email address you used to register. Please start registering by entering your data. | 9 May, 2024 | 17:00 CEST | 1 hour | Register |
| OXON's Free Live Webinar Series: Session 2 - Mastering RWE studies in the UK
OXON’s Free Live Online Webinar Series on RWE 'Unlocking Success: Mastering RWE Studies in the Healthcare Landscapes of Asia and Europe' Session 2: Mastering RWE Studies in the Healthcare Landscape of the UK Date: 13 June 2024 at 5pm CEST | 4pm BST | 11am EDT | 8am PST An understanding of the healthcare system in the UK and how medicine is practised within its context. In 60 minutes, delve into the heart of healthcare systems and data sources in the UK, empowering your proficiency in Real-World field, secondary data and hybrid studies with practical knowledge and advice to apply to your study for safety, HEOR/market access, drug development and marketing. Topics include: -Key demographic profile relevant to healthcare -Structure of healthcare -Clinical practice patterns -Data sources, their strengths and challenges -Strengths and challenges for field studies and use of innovative methodologies -Q&A session 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. Tom MacDonald Professor of Clinical Pharmacology & Pharmacoepidemiology, University of Dundee, and Honorary Consultant Physician at Ninewells Hospital and Medical School.. Webinar ID 428-954-643 Details: - We will be using GoToWebinar. - You can join our session by using a Mac, PC or a mobile device. - You will receive a confirmation email. Use the link to join the session, or login at https://global.gotowebinar.com/join and enter the 9-digit Webinar ID and the email address you used to register. Please start registering by entering your data. | 13 Jun, 2024 | 17:00 CEST | 1 hour | Register |
| FREE LIVE MASTERCLASS ON EXTERNAL CONTROLS FOR TRIALS: STRATEGY, SCIENCE, REGULATORS & HTAs
Free Live Online Masterclass on external controls for trials to learn about perspectives on external controls for one-arm and difficult-to-enrol trials from an epidemiologist/clinician and eminent medical statistician, illustrated with case studies. Attendees will learn how external controls from real-world data may accelerate new treatments for single-arm clinical trials in difficult-to-enrol populations and supplement controls in randomized controlled trials (RCT), and have their questions answered. Learning objectives: • Understand the challenges and expectations of regulators and HTA bodies for RW external controls. • How to develop a strategy to obtain fit-for-purpose RW natural history data. • How to develop a strategy to obtain fit-for-purpose RW external controls. • Appreciate how to design, analyse and synthesise RW external controls. • Learn from case studies. SPEAKER: Nawab Qizilbash MD MSc DPhil, Senior Clinical Epidemiologist, OXON Epidemiology Honorary Associate Professor in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine and Clinical Observer, Internal Medicine, Madrid Hospitals. Formerly: Honorary Consultant Physician, Radcliffe Hospitals, Oxford; Director, Clinical Epidemiology, GSK (supporting Clinical Development. Safety and Market Access) DISCUSSANT: Stuart Pocock, MA MSc PhD, Professor of Medical Statistics, London School of Hygiene & Tropical Medicine. Author of more than 600 papers (100+NEJM/Lancets), mainly of clinical trials and epidemiology; extensive experience of EMA/FDA and Data Monitoring Committees; Devised: Pocock Stopping Rule for trials; Win Ratio – accepted by FDA & EMA and increasingly used in trials; Individualising benefit risk. DETAILS: - We will be using GoToWebinar. - You can join our session by using a Mac, PC or a mobile device. | 19 Jun, 2024 | 17:00 CEST | 1 hour | Register |
| OXON's Free Live Webinar Series: Session 3 - Mastering RWE studies in Japan
OXON’s Free Live Online Webinar Series on RWE 'Unlocking Success: Mastering RWE Studies in the Healthcare Landscapes of Asia and Europe' Session 3: Mastering RWE Studies in the Healthcare Landscape of Japan Date: 11 July 2024 at 5pm CEST | 4pm BST | 11am EDT | 8am PST An understanding of the healthcare system in Japan and how medicine is practised within its context. In 60 minutes, delve into the heart of healthcare systems and data sources in Japan, empowering your proficiency in Real-World field, secondary data and hybrid studies with practical knowledge and advice to apply to your study for safety, HEOR/market access, drug development and marketing. Topics include: -Key demographic profile relevant to healthcare -Structure of healthcare -Clinical practice patterns -Data sources, their strengths and challenges -Strengths and challenges for field studies and use of innovative methodologies -Q&A session 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. Masao Iwagami Clinical Epidemiologist and Professor in the Institute of Medicine, University of Tsukuba, Japan, and Honorary Assistant Professor in the Faculty of Epidemiology and Population Health, LSHTM, UK. Webinar ID 428-954-643 Details: - We will be using GoToWebinar. - You can join our session by using a Mac, PC or a mobile device. - You will receive a confirmation email. Use the link to join the session, or login at https://global.gotowebinar.com/join and enter the 9-digit Webinar ID and the email address you used to register. Please start registering by entering your data. | 11 Jul, 2024 | 17:00 CEST | 1 hour | Register |
| OXON's Free Live Webinar Series: Session 4 - Mastering RWE studies in France
OXON’s Free Live Online Webinar Series on RWE 'Unlocking Success: Mastering RWE Studies in the Healthcare Landscapes of Asia and Europe' Session 4: Mastering RWE Studies in the Healthcare Landscape of France Date: 19 September 2024 at 5pm CEST | 4pm BST | 11am EDT | 8am PST An understanding of the healthcare system in France and how medicine is practised within its context. In 60 minutes, delve into the heart of healthcare systems and data sources in France, empowering your proficiency in Real-World field, secondary data and hybrid studies with practical knowledge and advice to apply to your study for safety, HEOR/market access, drug development and marketing. Topics include: -Key demographic profile relevant to healthcare -Structure of healthcare -Clinical practice patterns -Data sources, their strengths and challenges -Strengths and challenges for field studies and use of innovative methodologies -Q&A session 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: Dr Patrick Blin Pharmaco-Epi Senior Consultant, SNDS expert and Vice-president of the Ethics and Scientific Committee for Health Research, Studies and Evaluations (CESREES). Webinar ID 428-954-643 Details: - We will be using GoToWebinar. - You can join our session by using a Mac, PC or a mobile device. - You will receive a confirmation email. Use the link to join the session, or login at https://global.gotowebinar.com/join and enter the 9-digit Webinar ID and the email address you used to register. Please start registering by entering your data. | 19 Sep, 2024 | 17:00 CEST | 1 hour | Register |
| OXON's Free Live Webinar Series: Session 5 - Mastering RWE studies in Italy
OXON’s Free Live Online Webinar Series on RWE 'Unlocking Success: Mastering RWE Studies in the Healthcare Landscapes of Asia and Europe' Session 4: Mastering RWE Studies in the Healthcare Landscape of Italy Date: 24 October 2024 at 5pm CEST | 4pm BST | 11am EDT | 8am PST An understanding of the healthcare system in Italy and how medicine is practised within its context. In 60 minutes, delve into the heart of healthcare systems and data sources in Italy, empowering your proficiency in Real-World field, secondary data and hybrid studies with practical knowledge and advice to apply to your study for safety, HEOR/market access, drug development and marketing. Topics include: -Key demographic profile relevant to healthcare -Structure of healthcare -Clinical practice patterns -Data sources, their strengths and challenges -Strengths and challenges for field studies and use of innovative methodologies -Q&A session 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. Carlo Giaquinto, Professor of Paediatrics at the Department for Woman’s and Child’s Health of the University of Padova and President of Fondazione Penta. Webinar ID 428-954-643 Details: - We will be using GoToWebinar. - You can join our session by using a Mac, PC or a mobile device. - You will receive a confirmation email. Use the link to join the session, or login at https://global.gotowebinar.com/join and enter the 9-digit Webinar ID and the email address you used to register. Please start registering by entering your data. | 24 Oct, 2024 | 17:00 CEST | 1 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.