Posts tagged with "european"



28. September 2015
The correction to the harmonized standard for Magnesium Stearate has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG sign-off cover sheet. Having reached Stage 6 of the PDG process, the Magnesium Stearate monograph has been formally approved by the Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the Council of Experts. More
28. September 2015
The correction to the harmonized standard for Gelatin has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Gelatin monograph has been formally approved by the Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the Council of Experts. More
21. September 2015
Drugmakers in the EU have less than seven months to conduct risk assessments of all the excipients they use under good manufacturing practices guidelines imposed by the European Commission. The guidelines — which must be met by March 21, 2016 — require marketing authorization holders to assess their entire supply chains to identify risks to the safety and stability of excipients from their source through to their incorporation in finished dosage forms. More
02. March 2015
Drug Targeting Liposomes and Nanoparticles Oral Drug Delivery Pulmonary Drug Delivery Skin / Vaginal / Rectal / Nasal / Ear / Ocular Drug Delivery Smart Drug Delivery Systems Transdermal Drug Delivery Vaccine Delivery http://www.europeanmeeting.org/home/

21. August 2014
Julia Maier - EDQM ExcipientFest Europe - Amsterdam June 2014 http://www.excipientfest.com/europe/pdf/EFE14%20June%2025,%20AM%20Key%20Note%20FRC%20Characteristics%20of%20Excipients%20in%20the%20EP.pdf