2 Day Virtual Drug Development and Regulatory Approval Process Course: Key to Success from Concept to Commercialization Course - July 7th-8th, 2022 - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--The "Drug Development: Key to Success from Concept to Commercialization Course" training has been added to ResearchAndMarkets.com's offering.
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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
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/bjnbt5
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
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