EDQM’s 3R Activities in the Field of Quality Control of Vaccines

Theme I Safety and Efficacy Testing of Chemicals, Pharmaceuticals and Biologicals Session I-1: Potency and safety testing of human vaccines Session I-1: Oral presentations

the eDQM (european Directorate for the Quality of Medicines & Health Care, Council of europe) is a standard setting body involved in ensuring the quality of medicines, including vaccines for human and veterinary use. this is done through the elaboration and publication of the european Pharmacopoeia (Ph. eur.). In addition, the eDQM runs the Biological Standardisation Programme (BSP) which elabo...

Session I-16: Alternatives for potency testing of rabies vaccines Session I -16: Oral presentations

Vaccines are subject to requirements that regulate their quality and safety. Due to their biological origin, vaccines are complex products which can be influenced by various factors. As a result, each batch of the finished product is tested on potency and safety. the use of animals in batch release testing is a regulatory obligation and represents around 80% of the total number of animals used ...

Field Trial of Autoclaved Leishmania Vaccines for Control of Canine Visceral Leishmaniasis in Meshkin-Shahr, Iran

راه‌اندازی روش‌های آنالیتیک برای ارزیابی مختصات واکسن هپاتیت- B نوترکیب

Background: Hepatitis B vaccination has been included in routine immunization of all individuals according to WHO recommendations since 1991. Despite successful coverage, 3-5% of recipients fail to mount a desirable protection level of Ab. Vaccine failure results from: emergence of mutation, immune failure of individuals, decrease in vaccine potency, and etc. The quality of Hepatitis B va...

Evaluation of Quality of Two Commercial Oil-Emulsion Newcastle Disease Vaccines In-vivo and In-vitro

Background and Aims: Newcastle disease (ND) is a highly contagious disease in poultry with economic losses in the world. Vaccination is one of the most important ways for prevention and control of NDV, but there are reports of ND outbreaks in vaccinated chickens. Poor quality of the vaccines is one of the reasons of vaccine failure. In this study the quality of two commercial oil-emulsion Newca...