Human Medicines
Australia - TGA: CMEC Minutes - October 2007
Australia - TGA: Child-Resistant Packaging Stakeholder Consultation – January 2008
Australia - TGA: CMEC Meeting Dates 2008
USA - CBER: Cellular, Tissue and Gene Therapies Advisory Committee Meeting – February 2008
USA - CBER: Fast Track Designation Request Performance Report – January 2008
Veterinary Medicines
EU - EMEA: Requests for Advice from CMD(v) to CVMP
EU - EMEA: CHMP/CVMP QWP Work Programme 2008
EU - EMEA: Experts Lists – Update October 2007
EU - CVMP: "Sunset Clause" Q&A
EU - CVMP: PSURs for Veterinary Medicinal Products – Draft Guideline
General Healthcare
Australia - TGA: MDSOs & CASOs Stakeholder Consultation – January 2008
Denmark - DMA: Clear Objectives 2008
Denmark - DMA: Advanced Therapy Medicinal Products Regulation
USA - CBER: Fast Track Designation Request Performance Report – January 2008
EU - EMEA: Road Map: 2008-2009 Implementation Phase
Medical Devices
Australia - TGA: MDSOs & CASOs Stakeholder Consultation – January 2008
USA - CBER: Approved Biological Premarket Approval (PMA) Device Applications – January 2008
USA - CBER: Cleared Biological 510(k) Device Applications – January 2008
Australia - TGA: Medical Devices Transition – Update October 2007
Global - GHTF: Presentations from GHTF 2007
Conferences
Jobs
Clinical Project Manager
(07 Dec 2017)
CMC Regulatory Affairs Associate – Biopharma
(03 Jul 2008)
Regulatory Affairs Officer – Blue chip company
(03 Jul 2008)