By Nirpal Virdee, Global Head of Transparency & Disclosure Over the past several years, Ukraine has taken significant steps with its healthcare services in hopes of matching the high quality, modern healthcare provided in leading western countries. The Ministry of Health (MoH) of Ukraine continues to invest heavily in this ambitious goal. New legislation in … Continued
Background In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s (HC) Clinical Information … Continued
The 2018年12月22日 partial shutdown of the United States government affected roughly 25% of federal agencies, including the Food and Drug Administration (FDA), which has furloughed about 40% of its overall workforce. The duration of the shutdown is uncertain. In light of this uncertainty, it is important to understand the impact of the government … Continued
Even though the European Medicines Agency (EMA) has suspended publication of clinical data through Policy 0070 due to its Brexit business continuity plan, EMA posted a Policy 0070 external guidance update on 2018年11月11日. Revision 4 is now in effect. Policy 0070 External Guidance Update – Major Changes Several major changes are noted in this … Continued
The European Commission published a notice to stakeholders on September 6, reminding pharmaceutical companies of some unexpected impacts of Brexit in multiple areas, including the submission of clinical trial information to EudraCT. The submission of certain clinical trial information to the European Union (EU) database is a provision of an EU law which will no … Continued
Last week we shared Part I of our three-part series on the questions and clarifications we submitted to Health Canada regarding their draft guidance on the Public Release of Clinical Information. Many thanks to everyone who commented with their insight. Following is Part II. Please leave your comments below to keep the conversation going. Health … Continued
Synchrogenix’s experts and thought leaders have a pulse on the future impact of decisions made today, which is why we offer comments on global draft guidances on behalf of life science companies worldwide. Nirpal Virdee, Synchrogenix’s Director of Client Services and Technology, recently submitted feedback to Health Canada regarding their draft guidance on the Public … Continued
