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Webinars

Making AI Real in Medical Affairs

June 6, 2024 | 12:00 - 12:45 PM ET

Join us for the next webinar in our “Making AI Real” webinar series, where we will focus on practical applications of generative AI for Medical Affairs.

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Blog

Pharmaceutical Innovation: Italy’s AIFA Algorithm for Assessing New Products

Published April 8, 2022

The Assessment Process of Innovativeness of a New Medicine in Italy In April 2017, AIFA (Agenzia Italiana del Farmaco, Italian Medicines Agency) released an upgraded algorithm to assess and evaluate the level of innovativeness of new drugs seeking reimbursement from the EUR one billion innovative medicine fund made available by the Italian MoH (Ministero della Salute, Ministry of Health). The algorithm introduced in 2017 provides a multi-dimensional approach: innovativeness will be judged by AIFA’s CTS (Commissione Tecnico-Scientifica, Technical and Scientific…

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Webinars

Cross-Functional Collaboration: Winning Strategies for Medical-Commercial Success

Available On Demand

Join Trinity Life Sciences for a webinar that explores the findings from our TGaS report entitled, ‘Commercial and Medical Affairs Leaders Landscape 2022’. The study is based on the responses of 35 Commercial leaders and 24 Medical Affairs leaders representing 56 separate biopharmaceutical companies.  Commercial and Medical Affairs teams continue to play an important role in healthcare innovation and the value of having cross-functional collaboration is more critical than ever.   Join us for a dynamic discussion as we cover the…

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Blog

France Pilots Opportunity to Increase Speed to Reimbursement for Select Innovative Products

Published March 29, 2022

Executive Summary French president Emmanuel Macron announced a two-year trial that will allow pharmaceutical products that receive an ‘Amélioration du Service Médical Rendu’ (ASMR) rating of IV or better to get reimbursement immediately after the evaluation by the Transparency Committee (TC) In these cases, price negotiations will start while the new therapies are already on the market This new reform started in January 2022 as part of a two-year pilot project and is expected to significantly reduce the average time…

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White Papers

The Future of Leading Hybrid Conferences

The Example of ASH 2021 Medical conferences are designed to bring bright minds together and pique interest and curiosity. The American Society of Clinical Oncology (ASCO), American Society of Hematology (ASH), European Society for Medical Oncology (ESMO), Gene Therapy for Rare Disorders, and other medical conferences play an important role in disseminating clinical and scientific information. Attendees range from physicians to investors, and the conferences provide a forum for peer-to-peer interactions, exposure to current research, innovative trends and an environment…

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Blog

How Effective is ANVISA’s Rare Diseases Expedited Approval Pathway [RDC 205]?

Published March 18, 2022

Key Takeaways An analysis was conducted of all the orphan therapies registered by the FDA and ANVISA before and after 2018 to effectively evaluate approval times once the RDC 205 pathway was implemented. The main takeaways from the analysis can be found below:​ ​The difference between FDA and ANVISA time to approval for orphan drugs is four times shorter after the implementation of the RDC 205 / 2017 pathway​ The RDC 2015 pathway regulated the deadlines for the regulatory and…

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Webinars

Make Rapid Decisions with Confidence: Trinity’s Approach to Business Development Assessments

Available On Demand

Life science companies are often faced with situations that require quick decisions—from triage and/or pre-diligence phases through full due diligence. Trinity’s expert team routinely provides time-sensitive business development support, delivering robust insights and evidence-based answers in days. Come join us for a dynamic discussion on evaluating Business Development opportunities in life sciences. Key Webinar Topics What are the best approaches, data and tools to meet your business needs within your time horizon? How can you leverage rapid access to Real-World…

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Webinars

Demystifying Government Pricing: A Lens Into Industry Best Practices

Available On Demand

Companies frequently contract with various government channels as part of their contracting strategies. Each channel requires statutory price reporting, which drives manufacturer rebate calculations and/or provider reimbursement. With significant penalties for non-compliance and real financial impact on the bottom line, there is no room for error with government pricing calculations. Dynamic regulations add to the complexity. Join TGaS’ pricing and contracting experts for an exclusive webinar for pre-commercial and emerging life science companies. We will discuss common challenges that companies…

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Webinars

HTA/Reimbursement Evolution and Priorities for Assessment in a Value-Based Healthcare Environment in Latin America

Available On Demand

This session will discuss trends in the HTA/Reimbursement environment in Latin America and the drivers for value-based health care (VBHC) implementation within the region. The potential benefits of VBHC, stakeholders’ roles in VBHC, contextual barriers and facilitators for VBHC implementation, and potential future impact of VBHC to healthcare in the region will be discussed by a panel of speakers. Note: The webinar will be presented in Spanish and Portuguese with PowerPoint Slides shown in English.Dr. Hector Castro will moderate the session and…

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White Papers

Diversity in Clinical Trials Participation: A Life Sciences Perspective

Providing optimal care to all patients is an imperative that unites the various, interconnected parts of the medical field, from primary care to the pharmaceutical industry to the work of large academic medical centers. Over the past 30 years, there have been exceptional advances in care, treatment, diagnostics, and early identification of disease. Unfortunately, even with these many technological advances, addressing the importance of diversity has been lagging. Since the advent of clinical trials, recruitment has been largely centered on…

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Blog

EU Adopts Regulation on Pan-European Health Technology Assessment

Published February 18, 2022

Executive Summary A new pan-European Health Technology Assessment (HTA) regulation that will redefine the processes for the evaluation of new medicines in the EU entered into force in January 2022 Although it will not become fully active until 2025, the new regulation will require EU member states to give “due consideration” to joint clinical assessment (JCA) reports and provide feedback to the European Commission These new JCAs will only focus on the clinical domain of HTAs and thus they will…

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