Regulatory

Moving towards the development of mature quality management systems.

In this video interview, Jay Park, founder & scientific lead; and Rebecca Metcalfe, principal scientist, patient-centered research; both with Core Clinical Sciences, share their reactions to the FDA releasing its Diversity Action Plan Guidance.

In this video interview, Jay Park, founder & scientific lead; and Rebecca Metcalfe, principal scientist, patient-centered research; both with Core Clinical Sciences, discuss a recent article they authored on the guidance.

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, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how the guidance should prompt better-designed oncology trials and greater diversity.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, touches on challenges that may be created by the guidance such as meeting multiple regulatory requirements.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how sponsors will need to plan ahead even further for their oncology trials.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, highlights how FDA’s multiregional clinical trials in oncology guidance encourages more diverse site locations and patient populations.

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this video interview with ACT editor Andy Studna, Kashoki, SVP, global head of regulatory strategy, discusses the new draft guidance and its emphasis on proactive planning.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

Final guidance suggests sponsors select two doses for Phase II trials with additional data requirements.

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.