Regulatory Webinars
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Exploring The Interactions Between Validation, Technology Transfer
1/24/2024
Listen as Gerardo Gomez delves into the intricate relationship between validation and technology transfer, taking into account the perspectives and standards set by regulators.
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ICH E6(R3): Practical Steps For Implementation
12/14/2023
Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.
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Early Access Programs: What They Are And How To Plan For Them
12/5/2023
Explore how early access programs are tailored to individual sufferers of rare, ultra-rare, or life-threatening conditions, as well as cohort programs, which target groups of patients afflicted with the same disease.
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EU CTR: An Introduction To European Clinical Trial Transparency
12/4/2023
Listen in as regulatory expert Pierre-Frederic Omnes takes viewers through an overview of the European Clinical Trial Regulation (EU CTR) and its impact on clinical trials.
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Navigating The Unique Attributes Of Psychedelic Drug Development
11/21/2023
This session gives an overview of the recently published draft FDA guidance on psychedelics and how to efficiently adapt the recommendations for early phase clinical development.
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Navigating The Process Of Technology Transfer
11/14/2023
Olena Chervonenko, Associate Director Quality Management and Compliance at PharmaLex, provides deeper insights into technology transfer and essential factors for achieving success.
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Meeting Diversity Goals Through Smart Trial Design Strategies
11/8/2023
Delve into strategies for effectively monitoring and reporting progress toward achieving patient diversity objectives.
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An Overview Of Health Canada's CTA Process
10/24/2023
Experience expedited timelines by conducting trials in Canada. Our expertise in navigating Health Canada's CTA process ensures smooth and efficient approvals.
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The Advantages Of Conducting Early Phase Trials In North America
10/24/2023
In this webinar, Altasciences discuss the similarities and differences of conducting early phase research in North America versus other geographic regions.
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Big Changes Ahead For IRBs Regarding DCTs
10/18/2023
After reviewing the new FDA Guidance on DCTs, Dr. Daniel Fox, founder and CEO of the Clinical Research Payment Network (CRPN), predicts that IRBs are going to have their hands full in the future when it comes to the acceptance and adoption of DCTs.