1 Amendments of Carl SCHLYTER related to 2011/0402(CNS)
Amendment 146 #
Proposal for a decision
Annex 1 – part III – point 1 – point 1.11 – paragraph 1
Annex 1 – part III – point 1 – point 1.11 – paragraph 1
There is a need to support the development of scientific tools, methods and statistics for rapid, accurate and predictive assessment of the safety, efficacy and quality of health technologies including new drugs, biologics, advanced therapies and medical devices. This is particularly relevant for new developments in domains including those concerning vaccines, cell/tissue and gene therapies, organs and transplantation, specialist manufacturing, bio banks, new medical devices, diagnostic/treatment procedures, genetic testing, interoperability and e-health, including privacy aspects. Similarly, support for improvemodern hazard and risk assessment methodologies, testing approaches and strategies relating to assess chemicals with regard to their effects on the environment and health are required. There is also a need to support the development of relevant methods for assisting the assessment of ethical aspects of the above domains.