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TPLC (Total Product Life Cycle)

Total Product Life Cycle (TPLC) is an integrated device review, tracking, reporting and compliance scheme employed by FDA. The TPLC approach allows FDA to integrate all regulatory activities from device inception to obsolescence.
Czech Republic

Legislations

  1. Act No. 20/1996 on the Care for the Health of People
  2. Oviedo Convention on Human Rights and Biomedicine (2001)
  3. Act No. 130/2002 Collection on the Research and Development Support as Amended
  4. Act No. 378/2007 Collection on Pharmaceuticals
  5. Act on the Protection of Personal Data and on Amendment to Some Related Acts (No. 101 of April 4, 2000)


Regulations

  1. MOH: Decree No. 226/2008 on Good Clinical Practices and on Detailed Conditions for Evaluation of Pharmaceutical Products
  2. Position No. 3/2004 Personal Data Processing in the Context of Clinical Testing of Drugs and Other Medical Substances


Guidelines (SUKL):

  1. KHL-8: Clinical Trial Protocol and Protocol Amendments (1998)
  2. KLH-10: Terminology and Principles of Good Clinical Practice (1998)
  3. KLH-11: Ethics Committees (1998)
  4. KLH-19: Documentation Required for an Approval of a Clinical Trial on a Human Pharmaceutical (2001)
  5. KLH-20: Application for Approval/ Notification of a Clinical Trial (2004)
  		 

Opinion Poll

As per CDSCO-guidance for industry, which form is required Common Submission for Import Licence of Medical Devices in India?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
International Training course in Pharmacovigilance (20/05/13)
19th Asian Congress of Surgery & 1st SingHealth Surgical Congres (18/07/13)
22nd Annual ISAP Meeting (11/10/13)
17th World Congress of Pharmacology [WCP 2014] (13/07/14)

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