2014 - ADR Management and Reporting

Instructor: Sunil Verma
Description:
This webinar will address the procedures and requirements in regards to the collection, data management and reporting of suspected adverse drug reactions (ADR), Serious Adverse Events (SAEs), Suspected Serious Adverse Reactions (SSARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) associated with medicinal products for human use. It will further describe the procedure for safety reference document updates, safety alerts; drug recall, management of pregnancy and overdose reports.
Participants will gain a full knowledge on the global aspects of Pharmacovigilance, Pharmacovigilance regulatory guidelines, and different reporting systems with detailed description of the standard terminologies used in the field of Pharmacovigilance.
All medicinal products are required to be tracked via a firm testing and assessment procedures for their quality, efficacy and safety before being marketed. They should also be continually monitored to assure the safety, once they are placed into the market. Pharmacovigilance is the science and activities where we can detect and assess any safety related issues related to the medicinal product and the necessary measures can be taken. The main objective of Pharmacovigilance is to reduce the risks and increase the benefits of medicines. Despite 40 years of PV, patients worldwide continue to be affected by preventable harm from medicines. ADRs are among the top ten causes of mortality and the percentage of hospital admissions due to Drug Related events in some countries is about or more than 10%.
Why Should you Attend:
If you are involved in any aspect of pharmacovigilance and looking forward to strengthen your pharmacovigilance knowledge, this webinar will help you to increase your knowledge base regarding the techniques and regulatory processes involved in drug safety, pharmacovigilance, regulatory and quality compliance. This will be a perfect learning opportunity in all areas of drug safety, pharmacovigilance, regulatory and quality compliance and will be a great addition to your knowledge in pharmacovigilance.
Objectives of the Presentation:
Adverse Drug Reactions - Case Intake from different sources
Affiliate Workflow
Assessment of individual case reports
Aggregated data assessment and interpretation
Signal detection
Interactions and risk factors
Frequency estimation
Regulatory reporting - Individual and Aggregate reporting
A brief overview of ICH and other regulatory guidelines
Who can Benefit:
All Professionals are involved in:
Pharmacovigilance (including QPPV)
Clinical Research
Risk Management
Drug Safety Assessment Department
Safety Data Analysis
Pharmacoepidemiology
Information Technology
Regulatory Affairs
Pharmacovigilance consultancy
Quality and Compliance
Legal
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