Abstract
Pharmacovigilance is a broad field that spans across all stages of the life cycle from preclinical drug development, clinical development, marketing approval, and post-marketing use. This chapter will focus on the pharmacovigilance aspects of interventional clinical trials. It provides a brief overview over the key elements of protecting patients in clinical trials as well as collecting and reporting safety information for the purposes of developing the safety profile of an investigational medicinal product. Regulations and requirements across the globe are complex and national, while certain international standards through the ICH guideleines form a common basic platform through which multinational clinical trials can harmonise.
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References and Further Reading
Code of Federal Regulations (CFR) – Title 21 food and drugs – Chapter I food and drug administration (FDA), Department of health and human services – Subchapter D – Drugs for human use – Part 312 – Investigational new drug application
Directive 2001/20/EC of the European Parliament and of the council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
Enforcement Regulations of the Law on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (MHW ordinance no. 1, February 1, 1961). Final revision: MHLW ordinance no.82, April 10, 2015 and MHLW ordinance no.92, July 31, 2014 (to be enforced on June 12, 2017) article 273
European Commission – Communication from the Commission – Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’) (2011/C 172/01) June 2011
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – Guideline E2A – Clinical safety data management: definitions & standards for expedited reporting October 1994
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – Guideline E2D – Post-approval safety data management: definitions and standards for expedited reporting November 2003
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – Guideline E2F – Developmental safety update report (DSUR) August 2010
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – Guideline E2B (R3) clinical safety data management: data elements for transmission of individual case safety reports July 2013a
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – Guideline E2B (R3IWG implementation: electronic transmission of individual case safety reports July 2013b
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – Guideline E6 ‘good clinical practice’ (GCP) – R1 June 1996 and integrated addendum R2 November 2016
J-GCP Ordinance of the Ministry of Health and Welfare No. 28 of March 27, 1997 (As last amended by the ordinance of ministry of health, labour and welfare No. 161 of December 28, 2012) and guidance on the ministerial ordinance on the standards for the conduct of clinical trials of medicinal products (PFSB/ELD notification no. 1228/7 dated 28 December 2012)
Pharmaceutical Administration and Regulations in Japan (2017) (1.3 safety information on adverse reactions and infections during the study)
Regulation (EU) no 536/2014 of the European Parliament and of the council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing directive 2001/20/EC
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Heissing, R., van Troostenburg, AR. (2018). General Principles of Pharmacovigilance in Clinical Development. In: Hock, F., Gralinski, M. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Cham. https://doi.org/10.1007/978-3-319-56637-5_63-1
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DOI: https://doi.org/10.1007/978-3-319-56637-5_63-1
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