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.

[2]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”

Target Audience:

  • Pharmacovigilance Students, Scientists
  • Pharmacovigilance Researchers
  • Pharmacovigilance Faculty
  • Medical Colleges
  • Pharmacovigilance Associations and Societies
  • Business Entrepreneurs
  • Training Institutes
  • Software developing companies
  • Manufacturing Medical Devices Companies
  • Data Management Companies.[3]

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
  • Growth strategies in Pharma
  • PV Consulting's and Business opportunity
  • PV Data base management
  • Bio pharmaceutics
  • Clinical research and statistics
  • Good Pharmacovigilance practice
  • Continental Pharmacovigilance
  • Pharmacovigilance Significance and scope [4]


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. <ref>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121263/

Conference Highlights:

  • Drug Safety
  • Adverse Drug Reactions
  • Significance &Scope
  • Continental Pharmacovigilance
  • Good Pharmacovigilance Practice
  • and Risk Management
  • and Pharmacodynamics
  • -Clinical and Clinical Trials
  • Clinical Trials on Various Disorders
  • Clinical Research and Statistics
  • Case Report in Clinical Trials
  • PV Data Base Managemaent
  • Consultings And Bussiness opportunity
  • Regulatory affairs
  • Growth strategies in Pharma
  • Pharmacy Practices and its Challenges[5]

Drug Safety:

Drug Safety (Pharmacovigilance) is the Pharmacological science relating to the collection, detection, determination, control, and inhibiting of adverse effects with Pharmaceutical products. In this Track it is discussed about the Drug Safety and its applications in various fields.[6]

Adverse Drug Reaction:

An Adverse Drug Reaction (ADR) is a response to drug which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, analysis, or therapy of disease or for the modification of physiological function. Many Adverse Drug Reactions represent an excess of the drug's therapeutic effects Manufacturers, professionals, and consumers should report Post Marketing Reports on adverse effects. How we reduce the adverse drug reactions is discussed in Reduction of adverse drug reaction by Nanotechnology topic.[7]

Significance &Scope:

Pharmacovigilance and its Significance and Scope present the case for the importance of pharmacovigilance, to record its growth and potential as an important discipline within Medical science, and to describe its impact on patient welfare and public health and to know what is pharmacovigilance. In this track, we discussed about the Significance of pharmacovigilance. We also discussed on Pharmacovigilance role in healthcare system. Worldwide every year so many pharmacovigilance conferences were going on.[8]

Continental Pharmacovigilance :

Continental Pharmacovigilance gives an extension to Ensuring compliance with local and international requirements. To operate more efficaciously across multiple regions and Health authorities.[9]

Good Pharmacovigilance Practice:

Pharmacovigilance and Pharmacoepidemiology mainly deal to avoid the insufficient evidence of safety from clinical trials. To maintain the reporting practices avoid major problems in risk management. In addition, it is important to intensify on Signal investigation through observational studies and Interpreting safety signals. The pharmacovigilance Clinical Trials services companies must have the Pharmacovigilance Certification.[10]

Pharmacovigilance and Risk Management:

Pharmacovigilance and Risk Management plays major role in Drug industry. The new turn in Drug industry is to use Information technology in pharmacovigilance companies. Drug Industry need to promoting companies in pharmacovigilance practice and the Review of software’s used in pharmacovigilance and clinical trials. Monitoring unlicensed, off labels and orphan drugs is major task in Risk Management. In this conferences so many experts from different Pharmacovigilance CRO’s, Pharmacovigilance service providers were participates and shares their knowledge and discusses about the new updates. In this year, there is an International conference on Pharmacovigilance 2016, which is held in Austria on September 19-21.[11]

Pharmacokinetics and Pharmacodynamics :

Drugs may undergo, Pharmacokinetics and Pharmacodynamics and Toxicity testing through animal testing. This data allows researchers to allometrically estimate a safe starting dose of the drug for clinical trials in humans. In this track mainly we focused on Advances in pharmacodynamics interactions, Drug and substance abuse, Drug-Drug Interactions. Also discussed about the Pharmacy Practices to maintain the Pharmacokinetics and Pharmacodynamics and its Challenges and its guidelines. There are several Challenges in compounding and dispensing practice in Pharmacokinetics and Pharmacodynamics.[12]

Pre-Clinical and Clinical Trials:

The main goals of Pre-Clinical and Clinical Trials are to determine the safe dose and start to assess product's safety profile. In Designing of trials, there are pre-clinical studies and different phases of clinical trials. In this trails they estimate the Bioassay and its types. The Data collection and quality control is the major part in Pre-Clinical and Clinical Trials. For some specific drugs, there are some Alternative trials designs and models are used. Pre-Clinical and Clinical Trials are conducted as Multi center trials and monitoring basis. Each Pre-Clinical and Clinical Trials study of a drug, biological product, or medical device regulated by the FDA must be reviewed, approved, and monitored by the Regulatory authorities and ethics committee. There are several types of clinical trials like Clinical Trials on drugs used in respiratory disorders. Advanced Information technology in clinical trials improves the quality of Pre-Clinical and Clinical Trials.[13]

References

  1. ↑ http://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/
  2. ↑ Insert footnote text here
  3. ↑ https://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/
  4. ↑ https://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/
  5. ↑ https://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/
  6. ↑ https://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/
  7. ↑ https://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/
  8. ↑ https://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/
  9. ↑ https://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/
  10. ↑ https://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/
  11. ↑ https://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/
  12. ↑ https://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/
  13. ↑ https://pharmacovigilancecongress.pharmaceuticalconferences.com/2016/

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