ComplianceOnline

Nonclinical Drug Safety Evaluations in Drug Development

Instructor: Paula J Lapinskas
Product ID: 701527
  • Duration: 95 Min

recorded version

$299.00
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

$500.00
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 course is designed to provide a detailed overview of the role of toxicology in Drug Development. Participants will obtain an overall understanding of the principles of non-clinical safety evaluation with emphasis on application and interpretation of non-clinical safety data as it relates to and is integrated into the multi-disciplinary development plans and how it affects decision-making at each stage of the development process.

Why Should You Attend:
Toxicology or non-clinical safety assessment is an important component of the overall drug development plans for new drug candidates and biologics. Often project teams struggle with issues of potential "toxicity" of their product candidate and are uncertain as to how to use the data to make good development decisions at the different stages of the drug development process.

Course participants will come away with practical knowledge of non-clinical safety assessment to improve their understanding and interpretation of toxicology data at all stages of drug development.Case studies will be used to highlight how acceptable safety margins for different therapeutic areas are calculated, and how these affect the interpretation of toxicology data. The course is designed for non-toxicologists who want to build their knowledge of drug safety assessment and improve their interactions with toxicologists on your project team.

Areas Covered in the seminar:

  • Principles of toxicology as they apply to drug safety assessment.
  • Best practices in toxicology testing by drug development stage.
  • Determination and use of safety margin calculations at different stages of drug development: case studies.
  • Details of drug regulatory submissions: what the regulators want to see in terms of safety assessment.

Who will benefit:

This webinar will be valuable to all members of project development teams who want to develop a better understanding of drug safety assessment process and how the data should be used to make good development decisions. This course is designed for all those who come into contact with toxicology data, but who are not specialist toxicologists. No previous knowledge of toxicology is assumed. Participants who will benefit from this training include:
  • Project team members from preclinical and clinical development
  • Project management
  • Regulatory Affairs
  • Drug safety
  • Registration and data management
  • Management team members

Instructor Profile:
Paula J. Lapinskas, Ph.D. has a degree in molecular toxicology from Johns Hopkins university and has over 13 years industry experience in the pharmaceutical and biotech industry in the areas of regulatory and investigative toxicology with broad, leading edge experience in the development of drugs: from target validation to clinical development. Key successes in proactively identifying potential toxicity and other drug development issues (e.g. formulation, DMPK, ADME, etc.) and development of work plans to better assess potential risks and development huddles.

She has expertise in several therapeutic areas including: Immunology, Inflammation, oncology (multiple targets), Diabetes, CNS, Anti-infective, and signal transduction pathway modifiers. She is currently working as an independent toxicology consultant for both large and small pharmaceutical and biotech companies.

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