Regulatory Webinars
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FDA & ex-U.S. Product Approval
8/2/2023
Trial protocol strategies for FDA approval must also meet the needs of global regulators, if a therapy is to be commercialized worldwide. Michael Krams, chief quantitative medicine officer at Exscientia explains how R&D leaders should think about FDA and ex-U.S. product approval.
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Phase 2 Clinical Trials: What to Include (And What To Leave Out)
8/2/2023
How do drug developers make decisions about what to include, and what to leave out, of a Phase 2 clinical trial? Mitchell Katz, SVP, global clinical operations at Kyowa Kirin discusses collecting competitive intelligence and forging relationships with regulators.
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Avoiding Pitfalls With Your Product Development Strategy
8/2/2023
With over 15 years of experience in global drug development, Alex Klein brings a wealth of expertise to navigating challenges associated with regulatory affairs, business development, and marketing.
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Exploring The FDA's Draft Guidance On Psychedelic Drug Research
7/26/2023
Discover the crucial insights and methodological adaptations needed to effectively assess the safety, pharmacology, and efficacy of innovative psychedelic compounds designed for specific medical applications.
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Future Trends On European Regulations On Medicines
7/20/2023
Gain insight from regulatory experts regarding unmet medical needs, accessibility and affordability, the competitive and innovative European pharma industry, enhancing resilience, and the EU’s global voice.
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EU Regulations Impacting Medical Device & Drug Combination Product Developments
7/20/2023
Gain a better understanding of Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), by watching this presentation by regulatory experts.
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Navigating Regulatory Environments To Bring Products To Market
7/18/2023
Explore the opportunities and challenges presented by globalization in the pharmaceutical sector as explained by Dr. Jürgen Hönig, Senior Director of Regulatory Business Intelligence.
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Elevating Diabetes Trials To Align With Care Standards
7/17/2023
Watch as a panel of clinical experts specializing in diabetes care and clinical trial technology delve into the reasons why diabetes clinical trials have faced difficulties in keeping up with clinical care.
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Safety Reporting Requirements For Marketing In The EU
7/6/2023
Uncover the complexities of managing European pharmacovigilance legislation and the additional challenge of navigating individual requirements set by each EU Member State, which may implement regulations differently at the national level.
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Reshaping Decentralized Clinical Trials With Fit-For-Patient Solutions
7/6/2023
Unearth the potential of decentralized trials, as well as the technological and regulatory challenges which need to be considered in order to achieve success.