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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, June 14, 2022 (GLOBE NEWSWIRE) -- The "Drug Development: Key to Success from Concept to Commercialization Course" training has been added to ResearchAndMarkets.com'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 include 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
Agenda
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
Break
Regulatory submissions
The Common Technical Document
CTD modules
Regional administrative information
The application process for chemical and biologic drug products - US and EU
Break
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 https://www.researchandmarkets.com/r/voxx57
CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com 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
