Category Archive
The following is a list of all entries from the medical report category.
EMEA Publishes Comments Received on Development of Guidance for Products for Treating Smoking
Filed in EMEA,medical report, December 13, 2009, 8:54 amInterested party (Organisations or individuals) that commented on the draft Guideline as released for consultation
Drug Regulators Publish Q&A on ICH M2 – Common Technical Document for the Registration of Pharmaceuticals for Human Use
Filed in medical report,regulatory, October 21, 2009, 3:13 pmThis question and answer document is a summary of questions reviewed by the eCTD Implementation Working Group (IWG) on the eCTD SpecificationThis question and answer document is a summary of questions reviewed by the eCTD Implementation Working Group (IWG) on the eCTD Specification
EMEA re-posts Points to Consider on Missing Data
Filed in clinical,medical report,regulatory, May 29, 2009, 10:10 amThe EMEA has reposted points to consider a missing data, this points to consider was formally adopted in 2001, however the EMEA has chosen to repost this on the website
FDA Guidance for Industry – Intergrated Summaries of Effectivenss and Safety: Location within the Common Technical Document
Filed in clinical,medical report,regulatory,report, May 4, 2009, 8:20 pmThis new guidance focuses on where to place ISE and ISS documents within the structure of the CTD or eCTD. It does not outline in detail the content for the ISE and ISS. The content will be addressed in separate guidances.
Leukaemia – 60 years of progress – its what we work for.
Filed in medical report, October 28, 2008, 11:22 amI have just returned from most engaging presentation being held at the Nowgen centre in Manchester, the meeting entitled Leukaemia 60 years of Progress was a look a the progress we have made in treating Leukaemia in the past 60 years and I found it a massive boost to my moral and why I was [...]
