EMA Launches Vaccine Monitoring Project - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

EMA Launches Vaccine Monitoring Project


The European Medicines Agency (EMA) has announced the launch of Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE), a vaccine monitoring project. EMA, in collaboration with organizations involved in assessing the benefits and risks of vaccines, expects the project to “deliver a blueprint for a pan-European framework for monitoring the benefits and risks of vaccines throughout their lifecycle, and for communicating these benefits and risks,” according to an EMA press release

According to EMA, efforts to monitor vaccination coverage and the benefits and risks of vaccines after approval have been fragmented, and the goal of ADVANCE is to review, develop, and test methods, data sources, and procedures that will help to provide data for the assessment of vaccines. It is EMA’s hope that the project will provide health professionals, regulatory agencies, public health institutions, and the general public with the information needed to make better decisions regarding the use of vaccines.

The five-year project is supported by the Innovative Medicines Initiative (IMI) and involves EMA, the European Centre for Disease Prevention and Control, pharmaceutical companies, national public health and regulatory bodies, academic experts, and small and medium-sized enterprises. EMA will be responsible for developing and testing guidance that will include methodological standards, governance rules, a code of conduct, and a communication strategy. ADVANCE will be coordinated by the Erasmus Medical Center in the Netherlands and the Children’s Hospital Basel, University of Basel, Switzerland.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
30%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
30%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans

Click here