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September 11, 2023  •  Event

Virtual Panel on September 14: Solving Challenges for Advanced CGT Development

Join our team on Thursday September 14 for a virtual panel focused on Advanced CGT Development.

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September 6, 2023  •  Webinar

Predetermined Change Control Plans (PCCP) For AI/ML Software As Medical Devices (SaMD)

SaMD developers often face the challenge of determining whether a new marketing submission is necessary for certain software modifications. In a LinkedIn audio event, several experts from Biologics Consulting’s Medical Device Business Unit will discuss insights on how a PCCP can save you valuable time and resources by eliminating the need for post-market assessments and potential delays in the future. Connect with fellow industry leaders, learn from experts, and gain the knowledge you need to optimize your software modification processes and stay ahead in the ever-changing world of AI/ML SaMD.

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September 1, 2023  •  News

30 Days of Giving for 30 Years of Biologics Consulting

Help celebrate Biologics Consulting's 30th Anniversary by making a donation to Carpenter's Shelter during our 30 Days of Giving!

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August 9, 2023  •  Webinar

IND Timelines From a Former FDA Reviewer’s Perspective

Watch an on-demand webinar hosted by Biologics Consulting on the IND Review Timeline from a Former FDA Reviewer's Perspective.

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August 2, 2023  •  Event

Lunch & Learn on September 6: PCCP for AI-based SaMD

Join our Medical Device team on Wednesday September 6 for a Lunch & Learn covering PCCP for AI-based SaMDs.

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July 18, 2023  •  Podcast

eCTD 4.0 and Standardized Data with Ben Wimmer

Changes are coming to regulatory submissions publishing and we talk about two of them, eCTD 4.0 and standardized data, with Ben Wimmer.

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June 16, 2023  •  Event

Predetermined Change Control Plans (PCCP) for AI/ML Software as Medical Devices (SaMD) – LinkedIn Live Event

Join our medical device experts for a LinkedIn Live event on Wednesday June 21 covering Predetermined Change Control Plans (PCCP) for AI/ML Software as Medical Devices (SaMD).

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May 23, 2023  •  Podcast

“Weight of Evidence vs Carcinogenicity Testing (Part 2)” Featuring Bruce Pearce

Pharmacology and toxicology expert, Bruce Pearce, continues sharing his insight about the new FDA S1B guidance R1 addendum. These changes may allow you to forgo carcinogenicity testing in favor of a weight of evidence argument. On this episode of Insight at Biologics, we explore the many factors involved, including the 2 year rat and rasH2 mouse studies, pharmacologic mechanisms, toxicology studies, and more.

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April 20, 2023  •  News

Dr. Emily Place to present at TIDES USA event in San Diego

Biologics Consulting is proud to announce that Dr. Emily Place, Senior Consultant at Biologics Consulting, will be presenting at the upcoming TIDES USA Event.

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April 18, 2023  •  Podcast

“Weight of Evidence vs Carcinogenicity Testing (Part 1)” with Bruce Pearce

The ICH has released a new guidance which may allow you to forgo animal carcinogenicity testing in favor of a weight of the evidence argument. We begin our two-part discussion of why this has been added, including the goals of the addendum, on this episode of Insight at Biologics featuring expert Bruce Pearce. And, tune in next time for part 2 to find out how to go about this.

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