PMID- 31649864
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 2229-3485 (Print)
IS  - 2229-5488 (Electronic)
IS  - 2229-3485 (Linking)
VI  - 10
IP  - 4
DP  - 2019 Oct-Dec
TI  - Biovigilance: A Global Perspective.
PG  - 155-162
LID - 10.4103/picr.PICR_89_18 [doi]
AB  - A biological is a substance which either comprises, contains, or is derived from 
      human cells or human tissues. The use of biological products is associated with 
      the risk of infection transmission, allergic reactions, and other adverse events 
      (AEs). The science and activities relating to the detection, assessment, 
      understanding, and prevention of AEs or any other problems related to biological 
      products (blood, cells, tissues, organs, and vaccine in international 
      perspective) are termed as biovigilance. With more and more biologicals being 
      marketed and the rapid revolutionary changes in transplant-related services, the 
      importance of biovigilance is increasing day by day. Although specific types of 
      vigilance systems (pharmacovigilance and materiovigilance) exist, activities 
      related to "biovigilance" are still in an infancy stage. Many developed countries 
      such as the USA, Europe, and Australia have implemented nationwide biovigilance 
      programs. In India, the National Institute of Biologicals, in collaboration with 
      the Indian Pharmacopoeia Commission, has launched the Biovigilance Programme of 
      India. In this article, the biovigilance systems of different countries across 
      the globe have been reviewed along with highlights of the current biovigilance 
      needs.
CI  - Copyright: (c) 2019 Perspectives in Clinical Research.
FAU - Singh, Sukhjinder
AU  - Singh S
AD  - Department of Pharmacology, Post Graduate Institute of Medical Education and 
      Research, Chandigarh, India.
FAU - Chandel, Shammy
AU  - Chandel S
AD  - Department of Neurosurgery, Post Graduate Institute of Medical Education and 
      Research, Chandigarh, India.
FAU - Sarma, Phulen
AU  - Sarma P
AD  - Department of Pharmacology, Post Graduate Institute of Medical Education and 
      Research, Chandigarh, India.
FAU - Reddy, Dibbanti Harikrishna
AU  - Reddy DH
AD  - Department of Pharmacology, Post Graduate Institute of Medical Education and 
      Research, Chandigarh, India.
FAU - Mishra, Abhishek
AU  - Mishra A
AD  - Department of Pharmacology, Post Graduate Institute of Medical Education and 
      Research, Chandigarh, India.
FAU - Kumar, Subodh
AU  - Kumar S
AD  - Department of Pharmacology, Post Graduate Institute of Medical Education and 
      Research, Chandigarh, India.
FAU - Thota, Prasad
AU  - Thota P
AD  - Department of Pharmacology, Post Graduate Institute of Medical Education and 
      Research, Chandigarh, India.
FAU - Murali, Kotni
AU  - Murali K
AD  - Department of Pharmacology, Post Graduate Institute of Medical Education and 
      Research, Chandigarh, India.
FAU - Prakash, Ajay
AU  - Prakash A
AD  - Department of Pharmacology, Post Graduate Institute of Medical Education and 
      Research, Chandigarh, India.
FAU - Medhi, Bikash
AU  - Medhi B
AD  - Department of Pharmacology, Post Graduate Institute of Medical Education and 
      Research, Chandigarh, India.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - India
TA  - Perspect Clin Res
JT  - Perspectives in clinical research
JID - 101551517
PMC - PMC6801993
OTO - NOTNLM
OT  - Adverse events
OT  - biological products
OT  - biovigilance
COIS- There are no conflicts of interest.
EDAT- 2019/10/28 06:00
MHDA- 2019/10/28 06:01
PMCR- 2019/10/01
CRDT- 2019/10/26 06:00
PHST- 2019/10/26 06:00 [entrez]
PHST- 2019/10/28 06:00 [pubmed]
PHST- 2019/10/28 06:01 [medline]
PHST- 2019/10/01 00:00 [pmc-release]
AID - PCR-10-155 [pii]
AID - 10.4103/picr.PICR_89_18 [doi]
PST - ppublish
SO  - Perspect Clin Res. 2019 Oct-Dec;10(4):155-162. doi: 10.4103/picr.PICR_89_18.