scholarly journals An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 1447 ◽  
Author(s):  
Robert Carroll ◽  
Sreeram V. Ramagopalan ◽  
Javier Cid-Ruzafa ◽  
Dimitra Lambrelli ◽  
Laura McDonald
Keyword(s):  
Risk Assessment ◽  
Chart Review ◽  
Drug Utilisation ◽  
Data Capture ◽  
Primary Data ◽  
European Medicines Agency ◽  
Therapeutic Area ◽  
The European Union ◽  
Study Designs ◽  
The Eu

Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS) requested by the European Medicines Agency which were recorded on the European Union (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Methods: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18th October 2016. Results: We identified a total of 314 studies on the EU PAS Register, including 81 (26%) finalised, 160 (51%) ongoing and 73 (23%) planned. Of those studies identified, 205 (65%) included risk assessment in their scope, 133 (42%) included drug utilisation and 94 (30%) included effectiveness evaluation. Just over half of the studies (175; 56%) used primary data capture, 135 (43%) used secondary data and 4 (1%) used a hybrid design combining both approaches. Risk assessment and effectiveness studies were more likely to use primary data capture (60% and 85% respectively as compared to 39% and 14% respectively for secondary). The converse was true for drug utilisation studies where 59% were secondary vs. 39% for primary. For type 2 diabetes mellitus, database studies were more commonly used (80% vs 3% chart review, 3% hybrid and 13% primary data capture study designs) whereas for studies in oncology, primary data capture were more likely to be used (85% vs 4% chart review, and 11% database study designs). Conclusions: Results of this analysis show that study objectives and therapeutic area influence PAS design in terms of type of data capture used.

scholarly journals An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 1447 ◽  
Author(s):  
Robert Carroll ◽  
Sreeram V. Ramagopalan ◽  
Javier Cid-Ruzafa ◽  
Dimitra Lambrelli ◽  
Laura McDonald
Keyword(s):  
Risk Assessment ◽  
Chart Review ◽  
Drug Utilisation ◽  
Data Capture ◽  
Primary Data ◽  
European Medicines Agency ◽  
Therapeutic Area ◽  
The European Union ◽  
Study Designs ◽  
The Eu

Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS) requested by the European Medicines Agency which were recorded on the European Union (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Methods: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18th October 2016. Results: We identified a total of 314 studies on the EU PAS Register, including 81 (26%) finalised, 160 (51%) ongoing and 73 (23%) planned. Of those studies identified, 205 (65%) included risk assessment in their scope, 133 (42%) included drug utilisation and 94 (30%) included effectiveness evaluation. Just over half of the studies (175; 56%) used primary data capture, 135 (43%) used secondary data and 4 (1%) used a hybrid design combining both approaches. Risk assessment and effectiveness studies were more likely to use primary data capture (60% and 85% respectively as compared to 39% and 14% respectively for secondary). The converse was true for drug utilisation studies where 59% were secondary vs. 39% for primary. For type 2 diabetes mellitus, database studies were more commonly used (80% vs 3% chart review, 3% hybrid and 13% primary data capture study designs) whereas for studies in oncology, primary data capture were more likely to be used (85% vs 4% chart review, and 11% database study designs). Conclusions: Results of this analysis show that PAS design varies according to study objectives and therapeutic area.

scholarly journals Differences between the European and Eurasian Good Pharmacovigilance Practices

2021 ◽  
Vol 9 (2) ◽  
pp. 75-84
Author(s):  
A. V. Matveev ◽  
A. E. Krasheninnikov ◽  
E. A. Matveeva ◽  
B. K. Romanov
Keyword(s):  
Marketing Authorisation ◽  
European Medicines Agency ◽  
The European Union ◽  
Current Version ◽  
Eurasian Economic Union ◽  
Expert Analysis ◽  
The Russian Federation ◽  
Economic Union ◽  
Systems Effectiveness ◽  
The Eu

Good pharmacovigilance practices (GVP) of the Eurasian Economic Union (EAEU) were prepared based on the GVP of the European Medicines Agency that have been in force in the European Union (EU) since 2012. The EAEU GVP have been in force in the Russian Federation and the other EAEU member states since 2016. It is important to identify potential differences between the current regulations in order to harmonise requirements for the pharmacovigilance systems in the EU and EAEU. The aim of the study was to analyse and compare GVP requirements in the EU and EAEU. The analysis helped to identify differences in the structure and contents of GVP sections, the definitions of terms (EU GVP definitions are more detailed and supported by examples, subsections, and references to other documents). Moreover, supplements and annexes to the EU GVP contain figures, templates, examples, algorithms, and tables, which are missing in the EAEU GVP. Expert analysis of these differences as applied to assessment of the pharmacovigilance systems’ effectiveness, and practical activities of marketing authorisation holders, medicine developers, and regulatory authorities, demonstrated that the two GVPs are sufficiently harmonised and have very few differences. However, the number of differences between the documents increases, as changes are made to the EU GVP. A more comprehensive harmonisation of the EAEU GVP with the current version of the EU GVP will make it possible to develop and use uniform pharmacovigilance documents in the EU and EAEU, and will facilitate the introduction of EAEU medicines into the global pharmaceutical market.

scholarly journals National Food Safety Systems in the European Union: A Comparative Survey

2013 ◽  
Vol 2 (1) ◽  
Author(s):  
Andreas Hadjigeorgiou ◽  
Elpidoforos S. Soteriades ◽  
Anastasios Philalithis ◽  
Anna Psaroulaki ◽  
Yiannis Tselentis ◽  
...  
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Food Safety ◽  
The European Union ◽  
Member States ◽  
Eu Member States ◽  
Comparative Survey ◽  
Safety Systems ◽  
Central Level ◽  
The Eu

This paper is a comparative survey of the National Food Safety Systems (NFSS) of the European Union (EU) Member-States (MS) and the Central EU level. The main organizational structures of the NFSS, their legal frameworks, their responsibilities, their experiences, and challenges relating to food safety are discussed. Growing concerns about food safety have led the EU itself, its MS and non-EU countries, which are EU trade-partners, to review and modify their food safety systems. Our study suggests that the EU and 22 out of 27 Member States (MS) have reorganized their NFSS by establishing a single food safety authority or a similar organization on the national or central level. In addition, the study analyzes different approaches towards the establishment of such agencies. Areas where marked differences in approaches were seen included the division of responsibilities for risk assessment (RA), risk management (RM), and risk communication (RC). We found that in 12 Member States, all three areas of activity (RA, RM, and RC) are kept together, whereas in 10 Member States, risk management is functionally or institutionally separate from risk assessment and risk communication. No single ideal model for others to follow for the organization of a food safety authority was observed; however, revised NFSS, either in EU member states or at the EU central level, may be more effective from the previous arrangements, because they provide central supervision, give priority to food control programs, and maintain comprehensive risk analysis as part of their activities.

scholarly journals Cardiovascular Paediatric Medicines Development: Have Paediatric Investigation Plans Lost Heart?

Pharmaceutics ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 1176
Author(s):  
Bethany Faulkner ◽  
M. Begoña Delgado-Charro
Keyword(s):  
Cardiovascular Diseases ◽  
Health Technology ◽  
European Medicines Agency ◽  
Therapeutic Area ◽  
The European Union ◽  
Off Label Use ◽  
Off Label ◽  
Treat Heart Failure ◽  
Paediatric Medicines

This work aimed to establish whether paediatric needs in cardiovascular diseases have been met by paediatric investigation plans (PIPs) produced since the development of the European Union Paediatric Regulation in 2007. The European Medicines Agency repository was searched for patterns in the development of paediatric medicines in general. Next, positive PIPs related to cardiovascular diseases were scrutinized for outcomes and compared to specific paediatric cardiovascular needs. In total, 1866 PIPs were identified with 12% corresponding to decisions taken for cardiovascular medicines. However, despite this therapeutic area having the greatest number of overall PIPs, only 14% of established needs in paediatric cardiovascular diseases were addressed by PIPs with positive decisions. Further, 71.9% of PIPs with decisions in cardiovascular disease corresponded to full waivers, so the product would not be studied in paediatrics. Despite the progress found in overall numbers of PIPs published, cardiovascular products are still commonly used off-label in paediatrics. Particularly, there is a need to develop products to treat heart failure and hypertension, two areas with clear unmet clinical needs in paediatrics. A case study on valsartan showed that industry, regulators, health technology assessment bodies, and prescribers should work together to reduce off-label use of paediatric cardiovascular diseases (CVD).

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance: application to diabetes and vascular disease

2011 ◽  
Vol 11 (6) ◽  
pp. 304-307 ◽  
Author(s):  
Kevin V Blake ◽  
Camilla Smeraldi ◽  
Xavier Kurz ◽  
Peter Arlett ◽  
Stella Blackburn ◽  
...  
Keyword(s):  
Drug Utilisation ◽  
Real Life ◽  
European Medicines Agency ◽  
The European Union ◽  
Medicinal Products ◽  
European Network ◽  
Study Protocols ◽  
Real Life Setting ◽  
The Impact ◽  
Support Decision Making

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is an initiative led by the European Medicines Agency (EMA) aimed at further strengthening the post-authorisation monitoring of medicinal products in Europe by facilitating the undertaking of multi-centre, independent, studies focusing on safety and on benefit/risk. A key objective of ENCePP is to provide a unique point of access for all involved stakeholders, including industry or regulatory authorities, who are seeking collaboration for the commissioning or the performance of post-authorisation studies. The 2010 EMA regulatory action relating to rosiglitazone included a pharmacoepidemiological drug utilisation study to evaluate the benefit–risk profile in a real-life setting and has also led to the commissioning of an ENCePP study to evaluate the impact of risk-minimisation activities. ENCePP seeks to improve the European Union capacity to conduct such studies and thus support decision making. Application of the ENCePP study concept will result in an increase in trust in medicines and their use. In addition, the ENCePP register of studies will serve as a resource to allow for ready access to study protocols and results, thereby ensuring transparency.

scholarly journals Etyczne i prawne aspekty stosowania preparatu medycznego ellaOne czyli tzw. pigułki „pięć dni później”

2015 ◽  
Vol 13 (1) ◽  
pp. 9-34
Author(s):  
Andrzej Kobyliński
Keyword(s):  
European Union ◽  
Medicinal Product ◽  
Human Life ◽  
Legal Aspects ◽  
European Medicines Agency ◽  
The European Union ◽  
Medical Prescription ◽  
Postcoital Contraception ◽  
Emergency Contraceptive ◽  
The Eu

The article focuses on ethical and legal aspects of the use of the postcoital contraception. In November 2014, The European Medicines Agency recommended a change in classification status from prescription to non-prescription for the emergency contraceptive ellaOne. This medicinal product has been authorized in the European Union since 2009. The European Medicines Agency found that ellaOne could be used safely and effectively without medical prescription, which means that this medicinal product could be obtained without a prescription in the EU. The decision opens up a new stage of public debate about the beginnings of human life and recognition of the human embryo as a human being from the very moment of conception.

Quantitative risk assessment to compare the risk of rabies entering the UK from Turkey via quarantine, the Pet Travel Scheme and the EU Pet Movement Policy

2009 ◽  
Vol 138 (8) ◽  
pp. 1114-1125 ◽  
Author(s):  
V. RAMNIAL ◽  
R. KOSMIDER ◽  
O. AYLAN ◽  
C. FREULING ◽  
T. MÜLLER ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Companion Animals ◽  
Domestic Animals ◽  
Current Level ◽  
Quantitative Risk Assessment ◽  
The European Union ◽  
European Regulation ◽  
Annual Probability ◽  
The Uk ◽  
The Eu

SUMMARYRabies was eradicated from the UK in 1922 through strict controls of dog movement and investigation of every incident of disease. Amendments were made to the UK quarantine laws and the Pet Travel Scheme (PETS) was subsequently introduced in 2000 for animals entering the UK from qualifying listed countries. European Regulation 998/2003 on the non-commercial movement of pet animals initiated the European Union Pet Movement Policy (EUPMP) in July 2004. The introduction of EUPMP harmonized the movement of pet animals within the EU (EUPMPlisted) but raised the possibility of domestic animals entering the UK from a non-EU state where rabies is endemic (EUPMPunlisted). A quantitative risk assessment was developed to estimate the risk of rabies entering the UK from Turkey via companion animals that are incubating the disease and enter through PETS or EUPMP compared to quarantine. Specifically, the risk was assessed by estimating the annual probability of rabies entering the UK and the number of years between rabies entries for each scheme. The model identified that the probability of rabies entering the UK via the three schemes is highly dependent on compliance. If 100% compliance is assumed, PETS and EUPMPunlisted (at the current level of importation) present a lower risk than quarantine, i.e. the number of years between rabies entry is more than 170 721 years for PETS and 60 163 years for EUPMPunlisted compared to 41 851 years for quarantine (with 95% certainty). If less than 100% compliance is assumed, PETS and EUPMPunlisted (at the current level of importation) present a higher risk. In addition, EUPMPlisted and EUPMPunlisted (at an increased level of importation) present a higher risk than quarantine or PETS at 100% compliance and at an uncertain level of compliance.

scholarly journals Indonesian Government Strategies On Obtaining Crude Palm Oil (CPO) Market Access To European Union Countries Over The EU Parliament Resolution On Palm Oil And Deforestation Of Rainforest

2019 ◽  
Vol 8 (2) ◽  
pp. 203
Author(s):  
Bustanul Arifin ◽  
Komang Audina Permana Putri
Keyword(s):  
European Union ◽  
Palm Oil ◽  
Market Access ◽  
Primary Data ◽  
The European Union ◽  
Indonesian Government ◽  
The Republic ◽  
The Government ◽  
Export Destination ◽  
The Eu

Indonesia is the largest producer of palm oil in the world. With Malaysia, palm oil production could account for about eighty percent of global production. Meanwhile, Europe is the country with the third largest CPO export destination for Indonesia after India and China. However, the EU proposed a European Union resolution initiative on palm oil and deforestation of rainforest, which finally passed with the major votes from EU members of Parliament in April 2017. The key point on EU resolution reveals that EU will ban palm oil use for biofuels production by 2020. The purpose of this research is to analyze the Indonesian government’s diplomatic efforts to respond and negotiate with EU regarding the issue. It is also considered important to prevent the global downturn on palm oil products. To analyze the diplomacy effort, the researcher will use qualitative methods presented through data collection from sources such as books, journals, press releases and official reports from institutions in this case the European Union. To support the research, the researcher also uses primary data through the interview with one of the representative of the Ministry of Foreign Affairs of the Republic of Indonesia for diplomatic actions conducted by Indonesian government. This research finds that the government of Indonesian finally combined several soft diplomatic strategies to face EU both directly and indirectly.Keywords: Strategies, Government of Indonesia, Trade, Palm Oil, EU Resolution, Deforestation

scholarly journals Responsibilities of the Marketing Authorisation Holders in Respect of GMP Compliance (Review)

2020 ◽  
Vol 9 (4) ◽  
pp. 164-170
Author(s):  
A. P. Meshkovskiy ◽  
N. V. Pyatigorskaya ◽  
Z. I. Aladysheva ◽  
V. V. Beregovykh ◽  
A. M. Pyatigorskiy ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Marketing Authorisation ◽  
Good Manufacturing Practice ◽  
European Medicines Agency ◽  
The European Union ◽  
Related Quality ◽  
Ultimate Responsibility ◽  
Control Procedures ◽  
National Competent Authorities ◽  
The Eu

Introduction. The article is focused on differences in quality assurance-related obligations and responsibilities between Marketing Authorisation Holders (MAHs) and manufacturing authorisation holder (manufacturers) in pharmaceutical industry. In case of outsourcing and technical agreements there is a need to differentiate responsibilities related to quality assurance between the above mentioned categories.Text. The guidelines for the pharmaceutical sector of the European Union (EU) provide guidance on the responsibilities of the MAHs in relation to the GMP rules, which are scattered throughout the various chapters of the GMP and its appendices. In addition, certain provisions on this topic are contained in the EU directives. With this in mind the European Medicines Agency (EMA) issued in January 2020 a draft Reflection paper on Good manufacturing practice and Marketing Authorisation Holders. The draft clarifies that while certain activities of an MAH may be delegated to the manufacturer, MAH retains ultimate responsibility for the performance of a medicinal product, its safety, quality and efficacy. The important obligation of MAH in this context is to facilitate GMP compliance by establishing a robust two-way communication system with national competent authorities, manufacturing sites, Qualified Persons (QPs) certifying batches before release, and other interested parties. The MAH ought to communicate to manufacturing personnel, normally through QPs, production processes and related quality control procedures, including subsequent variations, described in registration dossiers.Conclusion. A general one conclusion: in view of rapid developments in the EU GMP Guide, the Eurasian Economic Union GMP requirements ought to be updated. In respect of specific responsibilities of MAH pertaining to GMP compliance the EMA draft Reflection paper merits attention as a guidance regarding separation of obligations and responsibilities between MAH and personnel of manufacturing sights.

Regulatory issues in blockchain technology

2017 ◽  
Vol 25 (2) ◽  
pp. 196-208 ◽  
Author(s):  
Peter Yeoh
Keyword(s):  
Financial Services ◽  
Secondary Data ◽  
Primary Data ◽  
The European Union ◽  
Content Type ◽  
The Public ◽  
Blockchain Technology ◽  
The Usa ◽  
The Eu

Purpose This paper aims to examine the key regulatory challenges impacting blockchains, innovative distributed technologies, in the European Union (EU) and the USA. Design/methodology/approach A qualitative perspective underpins the study. This paper relies on primary data from applicable statutes and secondary data from the public domain including relevant case study insights. Findings The smart regulatory hands-off approach adopted in the EU and the USA to a large extent bodes well for future innovative contributions of blockchains in the financial services and related sectors and toward enhanced financial inclusiveness. Practical implications The paper’s findings provide support for blockchain technology to advance with minimum regulatory brakes for greater value-adding and efficiency advancement, especially for financial services, thereby expanding accessibility and therefore financial inclusiveness. Originality/value This paper helps to draw greater attention to the technology underpinning virtual currencies. It also highlights other economic potentials flowing from blockchain advancement.

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