New Drug Applications – When is it ok to not submit data to FDA? Generally speaking, the FDA wants to see all data collected during drug development – all clinical trials, across all indications, using any formulation of your drug, in any region of the world.
Regulation (EC) No 1901/2006 (the “Pediatric Regulation”) introduced the obligation for Sponsors to apply for a pediatric investigation plan (PIP) early in the drug development process and conduct their pediatric clinical trials accordingly to a PIP agreed with the EMA. Compliance with the Pediatric Regulation is mandatory for any Sponsor seeking marketing authorization for a new medicinal product in the EU.
Are you developing a new medicinal product for a rare disease and interested in applying for orphan drug designation (ODD) in the European Union (EU)? This blog lists the main areas that you will need to address in your ODD application.
Dive into the complexities of GDPR compliance in clinical trials in Contract Pharma’s article, Understanding GDPR Compliance in Clinical Trials, an interview with Laura Gatavs, Head of Legal Department for Rho EU. Explore the nuances of when and where GDPR applies, grasp the basics of compliance – both at company compliance level and when negotiating clinical trial agreements – and uncover essential takeaways and best practices for clinical trial sponsors.
Rho’s Anna Pinsky, MD, PhD, Medical Director, and Elina Smirnova, Associate Director of Start Up Services Europe are featured in Applied Clinical Trials as they take a deep dive into the European regulatory landscape and share their insights on how US Sponsors can keep their European clinical trials on schedule and within budget.
Rho received Clinical Leader and Life Science Leader’s 2023 CRO Leadership award, marking a long history as an award recipient. Forty-six CROs were evaluated on more that 20 different performance metrics. Respondents evaluated companies with which they have worked on an outsourced project within the past 18 months. This level of qualification ensures that survey responses are based on actual involvement with CROs and clear experiential data.
Rho was recognized for Exceeding Customer Expectations in Compatibility and Quality and received 4 Individual Attribute Awards in Data Quality, Technology for Real Time Access to Data, Therapeutic Expertise and Operational Excellence.
