PL EN

Aktualności

EMA: Draft guideline on the use of bovine serum in the manufacture of human biological medicinal products

04.10.2012
This guideline replaces Note for Guidance on the use of bovine serum in the manufacture of human biological medicinal products (CPMP/BWP/1793/02). ...

EMA: Additional guidance on documents relating to an active substance master file

04.10.2012
Additional guidance on completing the Annex 2-letter of access, Annex 3-submission letter and administrative details for documents relating to an active substance master file and Annex ...

EMA: Paediatric addendum to CHMP guideline on clinical investigation of medicinal products in the treatment of lipid disorders

04.10.2012
This is an addendum to the Guideline on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (EMA/CPMP/3020/2003). It is not meant as a guidance document on its own but ...

GMP: The new EU GMP Chapter 1 in Pharmaceutical Development

27.09.2012
The Directorate-General for Health and Consumers (DG SANCO) of the European Commission has published the final version of the revised Chapter 1 of the EU-GMP Guide, which will now be called ...

GMP: The new EU GDP Guideline - What will happen next?

27.09.2012
In order to change the \"old\" Good Distribution Practices Guideline from 1994 the European Commission published a proposal for a new version. A large number of individuals, associations, ...

MHRA: Paracetamol overdose: new guidance on treatment with intravenous acetylcysteine

27.09.2012
New simplified guidance on treating paracetamol overdose with intravenous acetylcysteine is now in place. This includes an updated treatment nomogram. ...

EMA: Guideline on quality of transdermal patches - Draft

20.09.2012
This guideline together with the new Guideline on Quality of Oral Modified Release Products replaces the Note for Guidance on Modified Release products: A: Oral dosage Forms B: Transdermal Dosage ...

EMA: Guideline on quality of oral modified release products - Draft

20.09.2012
This guideline together with the Guideline on Quality of Transdermal Patches replaces Note for Guidance on Modified Release products: A: Oral dosage Forms B: Transdermal Dosage Forms. Part I ...

EMA: Concept paper on the involvement of children and young people at the Paediatric Committee (PDCO)

20.09.2012
This concept paper describes the European Medicines Agency\'s plans to develop a framework of interaction describing how the views of children and young people can be consulted as part of the ...

GMP: ICH Q8, Q9, & Q10 Questions and Answers - now also in force in the USA

13.09.2012
The ICH document Q8,Q9, & Q10, Questions and Answers / Appendix Q&As from Training Sessions has also been published in the United States. ...

kapitał ludzki

fundusz społeczny

Narodowe Centrum Badań i Rozwoju

innowacyjna gospodarka

rozwój regionalny