Planning for a Successful EMA Policy 0070 Submission
https://www.certara.com/article/planning-for-a-successful-ema-policy-0070-submission/
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Pharma Focus Europe – Issue 03 – Using AI to Accelerate Drug Development
Authors: Professor Amin Rostami-Hodjegan, Professor Piet van der Graaf This Pharma Focus EU article, co-authored by Amin Rostami-Hodjegan, SVP of Research & Development and CSO at Certara, and Professor Piet van der Graaf, SVP and Head of QSP at Certara, explores the integration of artificial intelligence (AI) in drug discovery, focusing on quantitative systems pharmacology … Continued
https://www.certara.com/article/pharma-focus-europe-issue-03-using-ai-to-accelerate-drug-development/Expert Answers to Your Questions on Developing EMA Policy 0070 Submissions
In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish all clinical studies submitted for regulatory approval. After almost five years of being offline (other than for COVID-19 submissions), the process and new standards that go along with Policy 0070 will likely be new to many sponsors looking to authorize … Continued
https://www.certara.com/blog/expert-answers-to-your-questions-on-developing-ema-policy-0070-submissions/RAPS Sponsored Webcast: How to Plan for a Successful EMA Policy 0070 Submission
In September 2023, the European Medicines Agency (EMA) will reinstate their Policy 0070 requirement to publish all clinical studies submitted to the EMA for regulatory approval. After almost five years of being offline (other than for COVID-19 submissions), the process and new standards that go along with Policy 0070 will likely be new to many … Continued
https://www.certara.com/on-demand-webinar/raps-sponsored-webcast-how-to-plan-for-a-successful-ema-policy-0070-submission/Recap of EMA’s Policy 0070 Restart Webinar
On 16 May 2023, the European Medicines Agency (EMA) held a webinar to announce plans to restart the publication of clinical data contained in regulatory submissions under Policy 0070. The Policy was originally suspended in 2018 as part of EMA’s Business Continuity Plan for its relocation in the wake of Brexit (read about it in … Continued
https://www.certara.com/blog/recap-of-emas-policy-0070-restart-webinar/Navigating EMA Policy 0070—How Do We Ensure Compliance?
Speaker Lora Killian provides insight on how EMA Policy 0070 will affect your organization and how to facilitate compliance, addressing many critical transparency and disclosure issues.
https://www.certara.com/on-demand-webinar/navigating-ema-policy-0070-how-do-we-ensure-compliance/P-gp Efflux Has No Impact on Dose Proportionality of Digoxin Bioavailability over a Dose Range of 0.125 To 1.5 Mg: The Outcome of a New PBPK Model, That Includes the In Vitro Transporter Information, is Consistent with the Clinical Observations
https://www.certara.com/poster/p-gp-efflux-has-no-impact-on-dose-proportionality-of-digoxin-bioavailability-over-a-dose-range-of-0-125-to-1-5-mg-the-outcome-of-a-new-pbpk-model-that-includes-the-in-vitro-transporter-information/
Quantitative Systems Pharmacology (QSP) Summit Cambridge 2024
The Quantitative Systems Pharmacology (QSP) Summit is a free conference dedicated to fostering an active community of industry and academic participants interested in topics relevant to QSP. In its seventh year, the QSP Summit is a one-day event featuring talks from key industry and academic researchers, a poster session, and networking time with peers. Date: May … Continued
https://www.certara.com/live-events/quantitative-systems-pharmacology-qsp-summit-cambridge-2024/AI-powered QSP Modeling
Location: MassBioHub, 700 Technology Square, 5th Floor, Cambridge, MA 02139 The proliferation of powerful AI models has revolutionized how the life sciences industry consumes information and uses it for accelerating and validating research. For example: One area where AI can provide immense value is in combination with QSP modeling to significantly accelerate the creation, expansion and validation … Continued
https://www.certara.com/live-events/ai-powered-qsp-modeling/Dose Optimization Considerations for Targeted Radiation Therapies
The acquisitions of targeted radiation therapy companies (TRT) Point Biopharma by Eli Lilly and RayzeBio by Bristol Meyer Squibb have sparked investors’ interest in this therapeutic class. A growing number of companies are now developing TRTs, and GlobalData reports that venture capital deals in the field have grown 550% to $408 million in 2023.1 The … Continued
https://www.certara.com/blog/dose-optimization-considerations-for-targeted-radiation-therapies/