PMID- 23598478
OWN - NLM
STAT- MEDLINE
DCOM- 20140512
LR  - 20130419
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 31 Suppl 2
DP  - 2013 Apr 18
TI  - A global regulatory science agenda for vaccines.
PG  - B163-75
LID - S0264-410X(12)01593-9 [pii]
LID - 10.1016/j.vaccine.2012.10.117 [doi]
AB  - The Decade of Vaccines Collaboration and development of the Global Vaccine Action 
      Plan provides a catalyst and unique opportunity for regulators worldwide to 
      develop and propose a global regulatory science agenda for vaccines. Regulatory 
      oversight is critical to allow access to vaccines that are safe, effective, and 
      of assured quality. Methods used by regulators need to constantly evolve so that 
      scientific and technological advances are applied to address challenges such as 
      new products and technologies, and also to provide an increased understanding of 
      benefits and risks of existing products. Regulatory science builds on 
      high-quality basic research, and encompasses at least two broad categories. 
      First, there is laboratory-based regulatory science. Illustrative examples 
      include development of correlates of immunity; or correlates of safety; or of 
      improved product characterization and potency assays. Included in such science 
      would be tools to standardize assays used for regulatory purposes. Second, there 
      is science to develop regulatory processes. Illustrative examples include 
      adaptive clinical trial designs; or tools to analyze the benefit-risk 
      decision-making process of regulators; or novel pharmacovigilance methodologies. 
      Included in such science would be initiatives to standardize regulatory processes 
      (e.g., definitions of terms for adverse events [AEs] following immunization). The 
      aim of a global regulatory science agenda is to transform current national 
      efforts, mainly by well-resourced regulatory agencies, into a coordinated action 
      plan to support global immunization goals. This article provides examples of how 
      regulatory science has, in the past, contributed to improved access to vaccines, 
      and identifies gaps that could be addressed through a global regulatory science 
      agenda. The article also identifies challenges to implementing a regulatory 
      science agenda and proposes strategies and actions to fill these gaps. A global 
      regulatory science agenda will enable regulators, academics, and other 
      stakeholders to converge around transformative actions for innovation in the 
      regulatory process to support global immunization goals.
CI  - Copyright (c) 2012 Elsevier Ltd. All rights reserved.
FAU - Elmgren, Lindsay
AU  - Elmgren L
AD  - Health Canada, Ottawa, Canada.
FAU - Li, Xuguang
AU  - Li X
FAU - Wilson, Carolyn
AU  - Wilson C
FAU - Ball, Robert
AU  - Ball R
FAU - Wang, Junzhi
AU  - Wang J
FAU - Cichutek, Klaus
AU  - Cichutek K
FAU - Pfleiderer, Michael
AU  - Pfleiderer M
FAU - Kato, Atsushi
AU  - Kato A
FAU - Cavaleri, Marco
AU  - Cavaleri M
FAU - Southern, James
AU  - Southern J
FAU - Jivapaisarnpong, Teeranart
AU  - Jivapaisarnpong T
FAU - Minor, Philip
AU  - Minor P
FAU - Griffiths, Elwyn
AU  - Griffiths E
FAU - Sohn, Yeowon
AU  - Sohn Y
FAU - Wood, David
AU  - Wood D
LA  - eng
PT  - Journal Article
PT  - Review
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Vaccines)
SB  - IM
MH  - Biomedical Research/standards
MH  - Drug Approval
MH  - Government Regulation
MH  - Humans
MH  - International Cooperation
MH  - Pharmacovigilance
MH  - Quality Control
MH  - Vaccination/*legislation & jurisprudence
MH  - Vaccines/*standards
EDAT- 2013/04/26 06:00
MHDA- 2014/05/13 06:00
CRDT- 2013/04/20 06:00
PHST- 2012/08/08 00:00 [received]
PHST- 2012/10/22 00:00 [revised]
PHST- 2012/10/31 00:00 [accepted]
PHST- 2013/04/20 06:00 [entrez]
PHST- 2013/04/26 06:00 [pubmed]
PHST- 2014/05/13 06:00 [medline]
AID - S0264-410X(12)01593-9 [pii]
AID - 10.1016/j.vaccine.2012.10.117 [doi]
PST - ppublish
SO  - Vaccine. 2013 Apr 18;31 Suppl 2:B163-75. doi: 10.1016/j.vaccine.2012.10.117.