Conversations in Drug Development Trends

MAY 1, 2024

The clinical trials sector prompted a recent modernization of ICH E8 and a subsequent renovation of ICH E6 to provide updated guidance that is appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources employed to support regulatory and other health policy decisions. Japan, and China.

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Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Download your copy today. In this complimentary webinar , Mel B. Watch the webinar.

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Cytel

JANUARY 23, 2023

Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has witnessed a steady rise in the search for new immunotherapies. This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology.

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Alta Sciences

MARCH 21, 2024

Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking. The complicated regulatory pathway for HAP requires individualized consulting for each type of study. Watch Now Speak with an expert today to learn more about our CNS solution.

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Alta Sciences

APRIL 17, 2024

With industry-leading solutions in the field of psychedelic drug development, and CNS drugs in general, our CNS Center of Excellence has supported numerous CNS drug development programs and is on the leading edge of the latest scientific knowledge in the field. Asia, and Europe.

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The Pharma Data

JANUARY 27, 2021

The Company is in late-stage clinical development and has been working toward establishing commercial readiness. This webinar will give current and prospective investors a clear vision of the Company’s goals for 2021 and beyond. About MultiStem ®.

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Advarra

JUNE 6, 2022

Advarra expert Steffen Engel answers questions from the recent webinar, Stepwise Implementation of a Clinical Quality Management System. A: The webinar discussed the following factors: Conduct a thorough assessment of each site’s QMS. A: That is a tough one. First, congratulations on realizing such a mindset may exist.

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The Pharma Data

DECEMBER 15, 2020

Company plans to meet with regulatory authorities as it evaluates next development steps. Company to host Key Opinion Leader (KOL) webinar to discuss these results today, December 16, at 8:00 am EST; registration link below. Interested parties can register for the webinar here. Kenilworth, N.J. ,

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The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. 1 The global rare disease market is forecasted to grow by a low double digit percentage in the future.

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Agency IQ

AUGUST 9, 2024

Following a recent AgencyIQ webinar, we collected dozens of questions from our subscribers and webinar attendees to put together this list of commonly-asked questions, as well as our attempts to answer them using available information. We’ve also collected additional questions that we have about the guidance.

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Agency IQ

APRIL 12, 2024

In an effort to further explain its current views on potency assurance, the FDA also recorded a webinar to accompany the new draft. The FDA’s revamp of the potency assay guidance extends these same principles to this other important aspect of product development, he emphasized. Should potency assurance plans be submitted? If so, how?

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Agency IQ

AUGUST 18, 2023

The registration database, EUDAMED , isn’t yet complete d, with just half of its planned modules released to production – actor registration, UDI and device registration, and Notified Bodies and certificates are live; still being worked on are the modules for clinical and performance studies, vigilance, and market surveillance.

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Agency IQ

DECEMBER 1, 2023

Start Date End Date Event Event Type Organization 12/01/2023 12/01/2023 BIVDA Environmental Working Party Webinar/Seminar ( CLOSED ) British In Vitro Diagnostics Association (BIVDA) 12/04/2023 12/04/2023 HMA/EMA Big Data Stakeholder Forum 2023 Webinar/Seminar ( OPEN ) European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) 12/04/2023 12/04/2023 (..)

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Agency IQ

AUGUST 2, 2024

While ASTP/ONC’s work is likely to be higher-level than FDA’s, the strategic plan on AI could, depending on its development, roll down to FDA policy. The HHS announcement also comes with a note that the Department will be hosting a webinar about federal workforce opportunities in this area.

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