Periodic Benefit-Risk Evaluation Report: A European Union Regulatory Perspective

2014 ◽  
Vol 28 (6) ◽  
pp. 309-315 ◽  
Author(s):  
Peter Arlett ◽  
Rodrigo Postigo ◽  
Heidi Janssen ◽  
Almath Spooner
Keyword(s):  
European Union ◽  
Risk Evaluation ◽  
Evaluation Report ◽  
Regulatory Perspective

Overview of Periodic Safety Update Reports: Where Have We Reached?

2020 ◽  
Vol 7 (1) ◽  
pp. 4-11
Author(s):  
Ruchika Sharma ◽  
Kamal Kant ◽  
Anoop Kumar
Keyword(s):  
Risk Assessment ◽  
Medicinal Product ◽  
Risk Evaluation ◽  
Future Perspectives ◽  
Evaluation Report ◽  
European Legislation ◽  
Benefit Risk Assessment ◽  
Periodic Safety ◽  
Periodic Safety Update Report

Periodic safety update report (PSUR) is now known as the Periodic Benefit-Risk Evaluation Report (PBRER). In July 2012, as per the new European Legislation, 16 Good Pharmacovigilance Practices (GVP) modules came into effect by replacing Vol 9A guidelines. GVP module VII provides the guidance for the preparation, submission and assessment of PSURs. There are twice as many sections to the new PSUR as compared to ICH E2C (R1) document and Volume 9A PSUR guidelines. The new legislation mainly focuses on benefit-risk assessment of medicinal product and promises much more, but after more than 6 years, how much new lesiglation is able to deliver is still unclear. In the literature, various articles have been published regarding the new Legislation module VII but none of them have highlighted the differences between old and new Legislation, How successful are we? What challenges are we facing? The understanding all these points is the need of the hour for Pharmacovigilance audience which will be helpful to implement the Pharmacovigilance (PV) in a more efficient and effective way. Thus, in this article, we have explained the differences between new and old Legislation and when they come into play. Finally, this article provides a brief examination of current challenges and future perspectives of periodic safety update reporting.

scholarly journals Prediction and risk evaluation of chalk cliff collapse: the PROTECT project

2004 ◽  
Vol 4 ◽  
pp. 89-92
Author(s):  
Stig A. Schack Pedersen ◽  
Ingelise Møller
Keyword(s):  
European Union ◽  
Risk Evaluation ◽  
Short Description ◽  
Public Access ◽  
Geological Survey ◽  
Northern Europe ◽  
The European Union ◽  
Rock Falls ◽  
Security Regulations ◽  
Practical Implications

A major cliff collapse took place at Store Stejlebjerg in the southern part of Møns Klint on 5 July 2003 (Fig. 1). This cliff collapse was one in a number of rock falls that has affected Møns Klint with a frequency of about one per five years. Geological investigations of the rock fall at Store Stejlebjerg were carried out by the Geological Survey of Denmark and Greenland (GEUS) after the Danish Forest and Nature Agency had asked for advice and help concerning security regulations for public access to the site. GEUS was prepared for this type of investigation due to the Survey’s engagement in the European Union project PROTECT, which aims at prediction of chalk cliff collapses. In this project a number of sites in northern Europe have been selected for detailed investigation, among which two are situated at Møns Klint, southeast Denmark (Fig. 1). This report provides a short description of the 2003 cliff collapse at Møns Klint and a brief description of the PROTECT project and its practical implications for cliff collapse evaluation.

scholarly journals COVID-19 Vaccination Strategy in Germany

2021 ◽  
Vol 12 (3) ◽  
pp. 46-49
Author(s):  
M. Pfeiffer-Ruiz ◽  
V. Schröder
Keyword(s):  
European Union ◽  
Risk Evaluation ◽  
Vaccination Strategy ◽  
Economic Damage ◽  
The European Union ◽  
High Demand

Vaccines are needed to reduce mortality and economic damage caused by COVID-19. To date there are three approved vaccines in the European Union created by BioNTech/Pfizer, Moderna and AstraZeneca, but due to the high demand globally there are still shortages, forcing governments to create strategies to immunize their population prioritizing their citizens according to their risk evaluation and their systemic relevance. This review specifies on the German vaccination strategy

scholarly journals Clinical Development of Gene Therapy Needs a Tailored Approach: A Regulatory Perspective from the European Union

2014 ◽  
Vol 25 (1) ◽  
pp. 1-6 ◽  
Author(s):  
Gopalan Narayanan ◽  
Giulio Cossu ◽  
Maria Cristina Galli ◽  
Egbert Flory ◽  
Hans Ovelgonne ◽  
...  
Keyword(s):  
Gene Therapy ◽  
European Union ◽  
Clinical Development ◽  
The European Union ◽  
Regulatory Perspective ◽  
Tailored Approach

scholarly journals COVID-19 Vaccination Strategy in Germany

2021 ◽  
Vol 12 (2) ◽  
pp. 31-34
Author(s):  
M. Pfeiffer-Ruiz ◽  
V. Schroder
Keyword(s):  
European Union ◽  
Risk Evaluation ◽  
Vaccination Strategy ◽  
Economic Damage ◽  
The European Union ◽  
High Demand

Vaccines are needed to reduce the mortality and economic damage caused by COVID-19. To date there are three approved vaccines in the European Union created by BioNTech/Pfizer, Moderna and AstraZeneca, but due to the high demand globally there are still shortages, forcing governments to create strategies to immunize their population prioritizing their citizens according to their risk evaluation and their systemic relevance. This review specifies on the German vaccination strategy.

scholarly journals Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective

2017 ◽  
Vol 103 (4) ◽  
pp. 564-566 ◽  
Author(s):  
Stefano Ponzano ◽  
Kevin Blake ◽  
Milton Bonelli ◽  
Harald Enzmann ◽  
Keyword(s):  
European Union ◽  
Clinical Research ◽  
Drug Candidates ◽  
Regulatory Perspective ◽  
Novel Drug
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