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Non-Clinical Drug Safety Evaluation and Drug Development

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Overview / Abstract:

Who Should Attend?
This course is designed for a broad range of pre-clinical, clinical, management, investment, and regulatory personnel in both established and emerging pharmaceutical and biological companies.

It will be of special value to:
• Scientists who wish to gain an understanding of pharmaceutical
toxicity studies
• Safety Professionals
• Regulatory Personnel
• Managerial personnel
• Early Clinical Project management staff
• Regulatory Scientist involved in preclinical development
• Investor
• Anyone interested in preclinical toxicology studies

Course Description
This 3-day intensive, accredited course offers a thorough dive into nonclinical development of drugs and biologics, including pharmaceutical toxicology and product safety assessment. Upon completion of this course, participants will have an understanding of the relationship between pharmacology, clinical trial design, how to build the safety profile, project management, and regulatory strategy. Tools will be provided to utilize EMA, FDA, and Health Canada regulations for new drug review process. The importance of toxicology study integration into development plans of new drugs and biologics and the impact of development decisions will be a pivotal part of this course. The goal of this training is to provide the framework for working knowledge of where pharmaceutical toxicology and drug development meet to streamline efficient compound trials. This is an interactive course, so bring all of your questions and scenarios.


Mar 22, 2019


Education (Higher Ed) , Miscellaneous


Live / Seminar, Seminar



Credits / Hours

1.8 CEUs



Presenters / Authors / Faculty

Michelleanne Bradley, President, Metis Consulting Services Inc.

Michelleanne Bradley is President of Metis Consulting Services Inc. She has over 15 years of experience in the Biotech and Pharmaceutical Industries. Ms Bradley has started drug safety departments for small organizations, acquisition integration for midsized organizations, and implementation with large organizations.

Ms Bradley is currently a pharmacovigilance and quality assurance consultant, performing site, company, and vendor audits, gap analysis, and oversight of drug safety database implementation. She has extensive experience with FDA and EMA audits and is a named consultant with a testing lab in the San Diego area. She is a graduate of the University of Georgia, Athens GA.

Keywords / Search Terms

CfPA CfPA CfPA pre-clinical, clinical, Early Clinical Project, Regulatory, development of drugs and biologics, EMA, FDA, and Health Canada regulations, pharmacology, clinical trial design, compound trials Seminar CE CME Seminar CE CME Seminar CE CME

LIVE Activity Location Details

02-20-2019 - 03-22-2019

Amsterdam, The Netherlands

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