Regulatory

Industry leaders share their perspectives on the guidance and how it will affect sponsors moving forward.

In this video interview with ACT editor Andy Studna, Kashoki, SVP, global head of regulatory strategy, discusses the new draft guidance and its emphasis on proactive planning.

In this video interview with ACT editor Andy Studna, Erin Erginer, director of product, Certara looks forward and shares her insights on the future of data management.

In this video interview with ACT editor Andy Studna, Erin Erginer, director of product, Certara discusses the lack of submission standards for clinical data.

Webinar Date/Time: Wed, Oct 23, 2024 11:00 AM EDT

Webinar Date/Time: Tuesday, November 12th, 2024 at 10am EST | 7am PST | 3pm GMT | 4pm CET

In this video interview with ACT editor Andy Studna, Rich Gliklich, founder of OM1 highlights existing guidances on real-world data and where there is room for even more oversight.

Session provides insight as to how to boost interoperability and expand the middleware on a global scale.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Xandra Neuberger, associate director, regulatory affairs, PharmaLex, discusses new strategies that companies can implement to properly shift to the new EU clinical trial framework.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Xandra Neuberger, associate director, regulatory affairs, PharmaLex, offers her thoughts on what EU clinical trial regulations companies need to be the most aware of.

The promise and acceptance of using this AI tool in drug development is growing.

Compliance with diverse clinical trial payment and data standards requires specialized skills.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Xandra Neuberger, associate director, regulatory affairs, PharmaLex, discusses the goals of the EU clinical trial regulation.

Preventing delays and accelerating the progression of these critical therapies.

A look at the insights and implications surrounding the agency's recommendations on using RWE from electronic health records and medical claims data.

DeOliveira, senior director, global regulatory operations, Cerevel (now part of AbbVie) highlights her experience in regulatory operations and how to address increased oversight from regulators.

According to a recent Phase II clinical trial conducted by Johns Hopkins Kimmel Cancer Center, all enrolled patients experienced a prostate-specific antigen reduction of 50% or more when treated with Olaparib.

In part 2 of this conversation, Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses the guidance and how it will affect sponsors moving forward.

Webinar Date/Time: Wednesday, September 11th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST

In part 4 of this video interview, Melissa Easy, VP commercial, digital products & solutions, IQVIA highlights how the regulators are addressing new technology with updated guidances.

Webinar Date/Time: Tuesday, September 10th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST

Webinar Date/Time: Tuesday, August 27, 2024 at 11:00 AM EDT | 8:00 AM PDT | 4:00 PM BST | 5:00 PM CEST

Webinar Date/Time: Tuesday, August 13th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST

Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit highlight the potential impact FDA's Diversity Action Plan guidance will have on industry.

Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit share their initial thoughts on the announcement of FDA's Diversity Action Plan guidance.

In an interview with ACT editor Andy Studna at DIA 2024, Beakes-Read, head, global regulatory policy and intelligence, Johnson & Johnson Innovative Medicine highlights the integration of technological advancements into drug development and benefits patients are seeing from FDA's Accelerated Approval Program.

Approval for Augtyro was based on results from the Phase I/II TRIDENT-1 trial, which demonstrated significant response rates in both tyrosine kinase inhibitor (TKI) naïve and TKI-pretreated patients.

Webinar Date/Time: Thursday, June 27th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST

Six trends to help guide trial master file strategy.

In the Complete Response Letter to Dynavax, the FDA stated that the supplemental Biologic License Application based on findings from the Phase I HBV-24 trial lacked sufficient data to support a full evaluation of the efficacy or safety of a four-dose Heplisav-B regimen in adults on hemodialysis.