BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:GMT Standard Time BEGIN:STANDARD DTSTART:20251002T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=2;BYMINUTE=0;BYMONTH=10 TZNAME:GMT Standard Time TZOFFSETFROM:+0100 TZOFFSETTO:+0000 END:STANDARD BEGIN:DAYLIGHT DTSTART:20250301T010000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=1;BYMINUTE=0;BYMONTH=3 TZNAME:GMT Daylight Time TZOFFSETFROM:+0000 TZOFFSETTO:+0100 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Please join our webinar. We'll have 2 presentations from widely known speakers:\nThe emerging and merging fields of benefit-risk and heal th technology assessments\nby Jason (Jixian Wang)\, Shahrul Mt-Isa and Sus an Talbot\, on behalf of the EFSPI BRA/HTA joint working group \nBenefit-R isk Assessment via Case Studies: Key Considerations and Best Practices \nb y George Quartey\nThe webinar occurs twice - please register for one of th e following dates:\n\n 1st webinar: 2017 February 9\, 5pm CET (4pm GMT) \n\n\n 2nd webinar: 2017 February 14\, 5pm CET (4pm GMT)\n\nClick here to view the flyer!\n\n \;Here is some further background information a bout the content and the presenters:\n \nThe emerging and merging fields o f benefit-risk and health technology assessments\n\nAbstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and a re often seen as purely regulatory activities\, while health technology as sessments (HTA) consider a wider range of aspects\, but mainly concentrate on economic evaluations. Despite different objectives\, the perspectives and requirements of the two domains are becoming more in sync than a decad e ago. This is evidenced by the formations of various initiatives to addre ss novel challenges\, raising the bar for those directly involved in provi ding justifiable evidence for decision-making on health technologies for t he good of public health. With increasing methodological demands and consi derations that are no longer unique to HTA or BRA in regulatory submission s\, more issues have surfaced and more questions have been raised. Despite the numerous efforts\, the recommendations remain diverse and the efforts remain distinct. The EFSPI/PSI joint working group for BRA and HTA has c onducted an extensive review of the initiatives and investigated methodol ogies to recommend practical approaches to improve HTA with an integrated BRA. We will present an up-to-date review of the outputs from key initia tives focusing on methodologies\, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies.\nAbout the pre senter: Jason (Jixian) Wang is a principle statistician at Celgene\, with over 25 years of experiences as statistician in a number of areas in pharm aceutical statistics\, has published more than 50 peer reviewed papers and a book on exposure-response modeling. He worked on health economics and outcome researches and epidemiology in academic institutes for several y ears before moving to industry positions supporting clinical pharmacology in Phase I-III trials and regulatory submissions\, with a number of succ essful NDA submissions to the FDA/EMEA . Since 2014\, he has been workin g on health economics and outcomes researches to support global market acc ess. His current interests are on health economics modeling\, real world evidence generation and causal inference\, and structured benefit-risk an d health technology assessments. He is a member of PSI special interest groups for real world data (formally epidemiology)\, modeling and simulati on and health technology assessment (HTA). He is leading a working group on clinical trial extrapolation for HTA\, and is a coordinator for the EF SPI joint working group for benefit-risk assessment and HTA.\n \;\nBen efit-Risk Assessment via Case Studies: Key Considerations and Best Practic es\n\nAbstract: The development and implementation of benefit-risk assessm ent is multi-faceted and should be done throughout the clinical developmen t life cycle. Use of structured benefit-risk framework could enhance regul atory decisions\, both in terms of scientific validity and in terms of con sistency and transparency to stakeholders. In this talk\, we describe two real examples that regulatory agencies considered in benefit-risk evaluati ons\, resulting in different outcomes in their approval and marketing stat us. These case studies illustrate a few key considerations (i.e subgroup i dentifications\, endpoint selection with important clinical impacts\, unce rtainty quantification\, risk mitigation etc.) for a full benefit-risk eva luation.\nAbout the presenter: Dr George Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years o f diverse experience in statistical research\, risk-benefit modeling\, com parative effectiveness research\, evidence synthesis and data Mining. He i s currently responsible for leading major innovation and enablement in are as relating to Benefit-Risk Assessment of Medicines\, Machine Learning and Predictive Safety Monitoring as well as Safety Strategies for Handling HT A. Dr Quartey published and spoke widely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several int ernal and external committees that inform policy on benefit-risk and quant itative safety methods including IMI PROTECT\, QSPI Benefit-Risk Working G roup and CIOMS X working group on "Evidence Synthesis and Meta-Analysis fo r Drug Safety". Dr Quartey is currently the co-director of the IMI EU2P pr ogram on benefit-risk assessment of medicines.\n\nTo access the recording\ , please visit the Video-on-Demand Library.\n DTEND:20170209T180000Z DTSTAMP:20260417T055721Z DTSTART:20170209T160000Z LOCATION: SEQUENCE:0 SUMMARY:Structured Benefit–Risk Assessment Webinar UID:RFCALITEM639120022410575393 X-ALT-DESC;FMTTYPE=text/html:Please join our webinar. We'll have 2 presenta tions from widely known speakers:\n

The emerging and merging f ields of benefit-risk and health technology assessments

\n

by Jason (Jixian Wang)\, Shahrul Mt-Isa and Susan Talbot\, on beha lf of the EFSPI BRA/HTA joint working group

\n

Be nefit-Risk Assessment via Case Studies: Key Considerations and Best Practi ces

\n

by George Quartey

\nThe webinar occurs twice - p lease register for one of the following dates:\n\n\nClick here t o view the flyer!
\n
\n \;Here is some further backgroun d information about the content and the presenters:\n \n

The emerging and merging fields of benefit-risk and health technology assessments

\njason
\nAbstract: Benefit-risk assessments (BRA) focus on clinical aspects of health care products and are often see n as purely regulatory activities\, while health technology assessments (H TA) consider a wider range of aspects\, but mainly concentrate on economic evaluations. Despite different objectives\, the perspectives and requirem ents of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel cha llenges\, raising the bar for those directly involved in providing justifi able evidence for decision-making on health technologies for the good of p ublic health. With increasing methodological demands and considerations th at are no longer unique to HTA or BRA in regulatory submissions\, more iss ues have surfaced and more questions have been raised. Despite the numerou s efforts\, the recommendations remain diverse and the efforts remain dist inct. The EFSPI/PSI joint working group for BRA and HTA has conducted an extensive review of the initiatives and investigated methodologies to rec ommend practical approaches to improve HTA with an integrated BRA. We wi ll present an up-to-date review of the outputs from key initiatives focusi ng on methodologies\, and will compare approaches taken by HTA authorities with those taken by the regulatory agencies.\nAbout the presenter: Jason (Jixian) Wang is a p rinciple statistician at Celgene\, with over 25 years of experiences as st atistician in a number of areas in pharmaceutical statistics\, has publish ed more than 50 peer reviewed papers and a book on exposure-response model ing. He worked on health economics and outcome researches and epidemiolog y in academic institutes for several years before moving to industry po sitions supporting clinical pharmacology in Phase I-III trials and regula tory submissions\, with a number of successful NDA submissions to the FDA /EMEA . Since 2014\, he has been working on health economics and outcomes researches to support global market access. His current interests are on health economics modeling\, real world evidence generation and causal in ference\, and structured benefit-risk and health technology assessments. He is a member of PSI special interest groups for real world data (formal ly epidemiology)\, modeling and simulation and health technology assessmen t (HTA). He is leading a working group on clinical trial extrapolation f or HTA\, and is a coordinator for the EFSPI joint working group for benefi t-risk assessment and HTA.\n \;\n

Benefit-Risk Assessment via Case Studies: Key Considerations and Best Practices

\ngeorg
\nAbstract: The development and implementation of benefit-risk assessment is multi- faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisio ns\, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk\, we describe two real examples that regulatory agencies considered in benefit-risk evaluations\, resulti ng in different outcomes in their approval and marketing status. These cas e studies illustrate a few key considerations (i.e subgroup identification s\, endpoint selection with important clinical impacts\, uncertainty quant ification\, risk mitigation etc.) for a full benefit-risk evaluation.\nAbout the presenter: Dr G eorge Quartey is a Strategic Innovation Leader for Safety Risk Management at Roche-Genentech with over 25 years of diverse experience in statistical research\, risk-benefit modeling\, comparative effectiveness research\, e vidence synthesis and data Mining. He is currently responsible for leading major innovation and enablement in areas relating to Benefit-Risk Assessm ent of Medicines\, Machine Learning and Predictive Safety Monitoring as we ll as Safety Strategies for Handling HTA. Dr Quartey published and spoke w idely on both theoretical and pragmatic aspects of benefit-risk assessment of medicines and served on several internal and external committees that inform policy on benefit-risk and quantitative safety methods including IM I PROTECT\, QSPI Benefit-Risk Working Group and CIOMS X working group on " Evidence Synthesis and Meta-Analysis for Drug Safety". Dr Quartey is curre ntly the co-director of the IMI EU2P program on benefit-risk assessment of medicines.
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\nTo access the recording\, please visit the Video-on-Demand Library.
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