EU Innovation and Competitiveness
Program Co-Chairs Iman Barilero, Johnson & Johnson PRD, and Marie Dray, International Regulatory Affairs Group USA, opened the first plenary session with introductions, sharing their vision of what the 18th Annual DIA EuroMeeting is all about: continuing themes throughout the meeting, including pediatrics, advanced therapies, technology platform, pharmacovigilance, risk management planning, and the involvement of patient groups.
Program Co-Chairs Iman Barilero, Johnson & Johnson PRD, and Marie Dray, International Regulatory Affairs Group USA, opened the first plenary session with introductions, sharing their vision of what the 18th Annual DIA EuroMeeting is all about: continuing themes throughout the meeting, including pediatrics, advanced therapies, technology platform, pharmacovigilance, risk management planning, and the involvement of patient groups.
Marie Dray mentioned that the EuroMeeting will continue Afssaps, involve patient groups, and develop the European Forum-asking regulators questions and discussing what is optimal regulation. Iman Barilero discussed the overall theme of the current environment for innovation and competitiveness in Europe.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.
