6th Pharmacovigilance Congress

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The “6th Pharmacovigilance Congress 2016” was held on September 28-30, 2016 in Toronto, Canada. The conference was organized by the Conferenceseries LLC. The field of Pharmacovigilance is growing rapidly and its development is making immense impacts in medical sciences and pharmaceuticals. 6thPharmacovigilance Congress accentuate on how the importance and significance can be gauged by the fact that it has made huge advancements over the course of time and is continuing to influence various sectors. The main theme of 6th Pharmacovigilance Congress is “Ensuring Drug Safety in Healthcare System”.[1]

Exhibition and Sponsorship

An Exhibition will be held concurrently with the Congress. The coffee break and lunch areas will be located adjacent to the booths. Thanks to exhibitors from all over the world, attendees will have a complete overview of new findings in the fields of Pharmacovigilance.

focus

Conference Series Ltd organizing gratifying Pharmaceutical conferences welcomes you to attend the 6th Pharmacovigilance Congress to be held during September 28-30, 2016 in Toronto, Canada focuses on the advancements in pharmacovigilance and risk management.

The field of Pharmacovigilance is growing rapidly and its development is making immense impacts in medical sciences and pharmaceuticals. 6thPharmacovigilance Congress accentuate on how the importance and significance can be gauged by the fact that it has made huge advancements over the course of time and is continuing to influence various sectors. The main theme of 6th Pharmacovigilance Congress is “Ensuring Drug Safety in Healthcare System”.

Area of focus

  • Drug Safety
  • Preclinical and Clinical Trials on Various Disorders
  • Pharmacy Practices and its Challenges
  • Adverse Drug Reactions
  • Case Report in Clinical Trials
  • Toxicology
  • Pharmacovigilance Risk management plans and new risk-benefit analysis tools
  • Pharmacokinetics and Pharmacodynamics
  • Regulatory Affairs
  • Clinical Data Management

DEVELOPMENT SAFETY UPDATE REPORTS During the clinical development of an investigational product, periodic analysis of safety information is crucial for the ongoing assessment of risk to trial subjects. Although both US FDA and EU Clinical Trial Directive required what is termed as IND Annual Report and Annual Safety Report, respectively, the content, format and timings differed between the US and EU reports.[7–9] Considering that most contemporary trials are multinational, a need was felt toward harmonizing these requirements and to provide a uniform standard acceptable to all regulators across the world. The concept of a Development Safety Update Report (DSUR) was first introduced by the CIOMS VI working group and taken forward by the CIOMS VII working group.[10] In 2008, the ICH published a draft guideline E2F (step 2) on DSUR, which has recently been updated (step 4, August 2010), incorporating background, objective and scope of DSUR and providing guidance on DSUR contents.[7]

The primary objective of DSUR is to present a comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period, related to a drug under investigation and not to provide initial notification of significant new safety information.[5] DSUR, being a cumulative report spanning over entire clinical development period, has unique value in identifying trends and patterns of safety issues related to an investigational product, which cannot be derived by looking at individual serious event reports in isolation.

Since CDSCO does not require DSUR, for Indian pharmaceutical companies undertaking global trial for a locally developed drug, Indian regulators will not have real-time update of the drug’s developing safety profile, while foreign regulators (such as ICH countries) having requirement of DSUR will have this information. This underscores the relevance of DSUR to Indian pharmaceutical companies undertaking indigenous drug development. With the global focus on DSUR, Schedule Y needs to be revised incorporating similar provision of providing cumulative safety updates to the regulators during clinical development phase.

[2]
  1. http://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121263/

    References

    1. http://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/
    2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121263/

      References

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