ComplianceOnline

How to establish Patient Benefit-Risk Assessments in Clinical Trials

Instructor: Ingrid Koster
Product ID: 701541
  • Duration: 46 Min

recorded version

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Last Recorded Date: Feb-2010

Training CD

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Read Frequently Asked Questions

Discussion on concept of risks and benefits in the context of an application for the new drug as a very complex process that requires significant evaluation of a large amount of data of patients, particularly those related to security.

Why Should You Attend:
During the development of clinical trials each member of the teams involved in the studies should be aware about the real / potential risks that may be identified by any information generated from clinical evaluation of the subjects. It should also be identified that there is still a high level of expertise, sometimes this does not match the high quality of data and, therefore, the impact of the monitoring of patient data must be continuously improved.

The objective of this presentation is to explain the concepts used to evaluate the benefit / risk to the applications market, the need to explore further development of appropriate methodologies for the analysis of benefit-risk clinical trials developed by pharmaceutical companies. We will also be discussing some points to improve the methodology, consistency, transparency and communication of risk-benefit assessment by the pharmaceutical industry.

Areas Covered in the seminar:

  • Why is a Benefit-Risk Assessment necessary.
  • What information is collected to obtain the Benefit-Risk Assessment.
  • Pharmacovigilance concepts for the Benefit-Risk Assessment.
  • From where does the information come from to obtain the Benefit-Risk Assessment?
  • How is used the information to obtain the Benefit-Risk Assessment.
  • How is the Benefit-Risk Assessment reported to Regulatory Authorities.

Who will benefit:
This webinar intends to provide expertise regarding clinical data for any member involved in clinical trials development among Pharmaceutical Industries

  • CROs
  • Vendors
  • Study Sites
  • Steering Committees
  • Consultants
  • Regulatory agencies

Instructor Profile:
Ingrid Koster, Epidemiologist, has worked in Clinical Research operations as Investigator and also as sponsor in the Pharmaceutical Industries along almost 15 years in Latin America. Ms Koster combines her background and current position in Public Health with her expertise in Research and Development within Pharmaceutical Industries to bring to us not only experiences in Clinical Trials management in several Therapeutic Areas but important insights to improve knowledge and perception for the major points regarding Clinical Research development.

Follow us :
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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