ComplianceOnline

Drug Safety Assessment and Risk Minimization in the Development Period

Instructor: Sheldon Brookman
Product ID: 701778
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$450.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This drug safety training will discuss the various factors to be considered and the principles of risk assessment to be followed during drug development to minimize risk.

Why Should You Attend:

With Pharmaceutical markets continuously on a growth path and industry consolidation proceeds with ongoing mergers and acquisitions and expanding biotechnology development, research and development productivity remains under increasing pressure to be efficient and cost-sensitive.

Well-managed development programs are economically critical to sponsors. Drug safety and risk minimization is based upon the principle of optimizing a balance between risk and benefit and they play a central role in the drug development process. The session will provide principles of risk assessment during drug development, where participants will learn about special considerations and measures that should be in place to minimize risk.

Areas Covered in the Seminar:

  • Risk conceptualization.
  • Goals of project risk management.
  • Risk management planning & safety review teams.
  • Intellectual property.
  • Pharmacovigilance planning in product risk management.
  • Unexpected study results: efficacy, dosage, adverse events & toxicology.
  • Data analysis, interpretation and presentation.
  • Essentials of Data Monitoring Committees.
  • Drug disposal and environmental impact.
  • Labeling as a hallmark of risk management efforts.
  • Post-marketing risk.

Who Will Benefit:

The Webinar will present valuable risk management information and provide a familiarity with practices to mitigate risk by pharmaceutical and biotechnology personnel involved in drug development, including:

  • Project managers
  • Managers in drug development
  • Clinical research associates
  • Regulatory and safety managers
  • Compliance associates

Instructor Profile:

Dr. Sheldon Brookman, is President of Clinical Decisions LLC, a consulting company providing clinical and regulatory development strategies. Sheldon has over 25 years of clinical and product development experience in the pharmaceutical industry and has held executive level development and regulatory positions with several pharmaceutical companies and CROs. He has designed and conducted more than four dozen Phase I through IV trials and has filed numerous regulatory submissions in the United States, Canada and South America. He was trained in Industrial Pharmacy at the University of Montreal, where he graduated with honors. Dr. Brookman also holds a PhD in Experimental Medicine and Surgery from the University of Montreal.

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