Search results with tag "Compassionate use"
Guideline on Compassionate use of Medicinal Products
www.ema.europa.euthe criteria and conditions for the compassionate use of new medicinal products under MS’ legislation”. Article 83 (1) of Regulation (EC) No 726/2004 introduces the legal framework for the provision of compassionate use in the European Union for medicinal products that are eligible to be authorised via
Questions and answers on the compassionate use …
www.ema.europa.euQuestions and answers on the compassionate use of medicines in the European Union EMEA/72144/2006 (rev) Page 2/3 How do compassionate use programmes work?
DEVELOPMENT SAFETY UPDATE REPORT - ICH
database.ich.orgtherapeutic use trials (Phase IV)); • Therapeutic use of an investigational drug (e.g., expanded access programmes, compassionate use programmes, particular patient use, single patient INDs, and treatment INDs); and • Clinical trials conducted to support changes in the manufacturing process of medicinal products.
The supply of unlicensed medicinal products (“specials”)
assets.publishing.service.gov.ukproducts supplied for compassionate use in accordance with Article 83 of Regulation (EC) 726/2004 ... 1.7 The manufacture and distribution of veterinary unlicensed medicinal products for animal use is subject to separate legislation. Further advice should be sought from the Veterinary Medicines Directorate (VMD) of DEFRA. ...
医薬品のコンパッショネート使用制度（CU）
lifescience.co.jpJpn Pharmacol Ther（薬理と治療）vol. 40 no. 10 2012 832 はじめに 欧米で制度化されているコンパッショネート使用 制度（compassionate use: CU）の日本への導入の議
Compassionate Use Policy - Regeneron Pharmaceuticals
www.regeneron.comCompassionate Use Policy In the USA, this type of compassionate use program is also known as an Expanded Access Program (EAP) and is intended for patients with serious or life-threatening conditions who do not have any viable or available treatment options and are unable to participate in ongoing clinical trials.
Compassionate Self Help - Getselfhelp.co.uk
www.getselfhelp.co.ukUse Compassionate Self Talk We all have internal dialogue in our heads, it is very often self critical and we judge ourselves far harsher than the way we judge other people. We can practise noticing when we do that, and start to use Compassionate or Kind Mind. • Bring your Compassionate Image to mind.