Australia: Updated Clinical Trial Handbook

On March 15, Australia’s Therapeutic Goods Administration (TGA) published a revised version of their Clinical Trial Handbook[i]. The updated handbook provides guidance on the legal framework for conducting clinical trials of unapproved therapeutic products in...

Marken Appoints New Vice President, Global Quality Assurance

Dr. Navnit Patel to Focus on Expanding the Company’s Market-Leading Quality Systems Research Triangle Park, North Carolina, February 20, 2018 – Marken is pleased to announce the appointment of Navnit Patel, Ph.D., as Vice President, Global Quality Assurance, effective...

Argentina: Procedural Changes to the 9-point Form Submission

As of February 1, 2018, Argentina’s Ministry of Health (ANMAT) is only accepting the 9-point inspection information required for the export of biologic specimens via the TAD electronic system. Paper versions of the 9-point inspection previously used by the agency will...