tailieunhanh - Medicines & Medical Devices Regulation: What you need to know

The sequencing of the human genome together with the development and implementation of new high throughput technologies (so called “omics”) are enhancing our knowledge on human health and disease and have already, and will continue, to provide a sound foundation for personalised medicine. The workshop “Omics in personalised medicine” that was held at the European Commission in Brussels on 29th and 30th of April, brought together experts from different fields: omics, epidemiology, pharmacology, experimental medicine and bioinformatics representing academia, industry, including SMEs, and regulatory and funding agencies. The aim of the workshop was to explore the. | Safeguarding public health through the effective regulation of medicines and medical devices Medicines Medical Devices Regulation What is the MHRA 2 When is a product acceptably safe 2 The history of UK regulation 3 How does the MHRA work 4 How does licensing and authorisation work 5 How is a medicine licensed 5 Monitoring new medicines and vaccines 6 How are devices authorised 7 What the MHRA licenses authorises 7 Herbal medicines and homeopathic remedies 8 Why are clinical trials important 9 How does the MHRA monitor safety and 10 quality standards Safety and quality standards 10 Why is the General Practice Research 11 Database important A patient s view of the Yellow Card Scheme 12 What happens when quality or safety 13 concerns arise Dealing with faulty medicines 14 Responding to concerns about devices 16 How device reporting makes a difference 17 Is it safe to order medicines and devices off 18 the internet Influencing Policy 19 Medicines Medical Devices Regulation