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2 Day Virtual Drug Development and Regulatory Approval Process Course: Key to Success from Concept to Commercialization Course - July 7th-8th, 2022 -

DUBLIN--(BUSINESS WIRE)--The "Drug Development: Key to Success from Concept to Commercialization Course" training has been added to's offering.

The course begins by considering the global pharmaceutical market, important therapeutic areas and the roles of different Pharmaceutical professionals in the development process, as well as a definition of drugs and medical devices.

Course includes the identification of drug targets, synthesis of chemical drugs and the development of biologics, pharmacokinetics and toxicity screening, pre-clinical development, clinical studies, regulatory submissions, managing post-approval change, pharmacovigilance and an overview of regulations governing drug manufacture and distribution.

The drug development process, from discovery to post-marketing surveillance, is then explained. This course is designed to teach employees of pharmaceutical companies who would like an understanding of the drug development and regulatory approval process.

Learning Objectives:

  • Roles of different pharmaceutical professionals
  • Typical costs and timelines associated with drug development
  • How new drugs are developed against targets in the human body
  • The structure of regulatory submissions
  • Reasons why drugs fail during development process
  • Factors affecting oral bioavailability
  • The size of the global pharmaceutical market and the key therapeutic areas being addressed by innovator companies
  • How drugs are screened for toxicity
  • The potential influence of polymorphism, salt form and isomerism on efficacy and safety
  • How formulation can affect drug performance
  • How the safety and efficacy of drug products are ensured during QC release testing
  • The information obtained at each stage of clinical research
  • How post-approval changes to drug products are managed
  • How the manufacture and distribution of marketed drug products are controlled


Drug Development Products Overview

  • Product types and routes of administration
  • The drug development process
  • Risks in drug development

The International pharmaceutical market

  • Market shares of chemical and biological drugs
  • Roles of drug development professionals
  • Size and key therapeutic areas
  • Regional differences

Drug discovery

  • Drug targets
  • The Human Genome Project
  • Lead compound identification and optimisation


Regulatory submissions

  • The Common Technical Document
  • CTD modules
  • Regional administrative information
  • The application process for chemical and biologic drug products - US and EU


Pre-clinical development

  • Optical isomerism
  • Formulation options for improving bioavailability
  • Common formulation types
  • Critical quality attributes
  • In-process controls and release testing
  • Polymorph and salt form screening
  • Solubility, permeability and oral bioavailability

Clinical research

  • Clinical study design
  • Clinical development Phases
  • Establishing safety and efficacy/bio equivalence
  • Adverse event reporting
  • Impact of mobile computing on clinical research

Pharmacokinetics and toxicity

  • Drug plasma concentration profiles
  • Absorption, distribution, metabolism and elimination of drugs
  • First-pass metabolism
  • Types of toxicity screening

Break 15 mins

Post-approval change

  • Problems concerning product improvement
  • New ICH Q12 - the promise of easier post-approval change
  • Current situation

US and EU Pharmacovigilance

Important elements of regulation

  • Drug product manufacture
  • Distribution
  • ICH guidance

Final questions, feedback and close

For more information about this training visit

Laura Wood, Senior Press Manager

For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

Editor Details

  • Company:
    • Businesswire
Last Updated: 08-Jun-2022