The US Food and Drug Administration-European Medicines Agency Collaboration in Pharmacovigilance: Common Objectives and Common Challenges

Drug Safety

Volumn 38, Issue 1, 2015, Pages 13-15

  Dal Pan, Gerald J ^a   Arlett, Peter R ^b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL (TOPIC); CONFIDENTIALITY; DECISION MAKING; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; DRUG MONITORING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EDITORIAL; EUROPE; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE SYSTEM; PRIORITY JOURNAL; RISK MANAGEMENT; UNITED STATES; COOPERATION; GOVERNMENT; HUMAN; INTERNATIONAL COOPERATION; ORGANIZATION AND MANAGEMENT;

COOPERATIVE BEHAVIOR; EUROPE; GOVERNMENT AGENCIES; HUMANS; INTERNATIONAL COOPERATION; PHARMACOVIGILANCE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84925539785     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-014-0259-3     Document Type: Editorial

References (5)

1. US Food and Drug Administration. FDA and European Medicines Agency strengthen collaboration in pharmacovigilance area. [Press release; 19 Feb 2014]. Available at: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm386372.htm. Accessed 20 Dec 2014
2. European Medicines Agency. European Medicines Agency and US Food and Drug Administration strengthen collaboration in pharmacovigilance area. [Press release; 19 Feb 2014]. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/02/news_detail_002028.jsp&mid=WC0b01ac058004d5c. Accessed 20 Dec 2014
3. http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/document_listing/document_listing_000228.jsp&mid=WC0b01ac058003176e#section1. Accessed 20 Dec 2014
4. European Medicines Agency. Pharmacovigilance legislation. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000491.jsp&mid=WC0b01ac058058f32d. Accessed 20 Dec 2014
5. Arlett P, Portier G, de Lisa R, Blake K, Wathion N, Dogne JM, Spooner A, Raine J, Rasi G. Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee. Nat Rev Drug Discov. 2014;13(5):395–7.