DUBLIN–(BUSINESS WIRE)–The “The Drug Development Process from Concept to Market” training has been added to ResearchAndMarkets.com’s offering.
This course is designed to cater for employees of pharmaceutical companies who would like an understanding of the drug development and regulatory approval process.
The course starts 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. The drug development process, from discovery to post-marketing surveillance, is then explained.
Topics 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.
Learning Objectives:
By the end of this course, you will understand:
- The size of the global pharmaceutical market and the key therapeutic areas being addressed by innovator companies
- The roles of different pharmaceutical professionals
- Typical costs and timelines associated with drug development
- How new drugs are developed against targets in the human body
- Reasons why drugs fail during development
- Factors affecting oral bioavailability
- 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
- The structure of regulatory submissions
- How post-approval changes to drug products are managed
- How the manufacture and distribution of marketed drug products are controlled
Key Topics Covered:
Day 01 (10:00 AM – 5:00 PM EST)10:00 AM -11:00 AM
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The global pharmaceutical market
- Size and key therapeutic areas
- Regional differences
- Market shares of chemical and biological drugs
- Roles of drug development professionals
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Overview – development of drug products
- Product types and routes of administration
- The drug development process
- Risks in drug development
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Drug discovery
- Drug targets
- The Human Genome Project
- Lead compound identification and optimization
11:00 AM -11:15 AM Break11:15 AM -12:00 NOON
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Pharmacokinetics and toxicity
- Drug plasma concentration profiles
- Absorption, distribution, metabolism and elimination of drugs
- First-pass metabolism
- Types of toxicity screening
12:00 NOON -1:00 PM Lunch1:00 PM -2:00 PM
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Pre-clinical development
- Polymorph and salt form screening
- Solubility, permeability and oral bioavailability
- Optical isomerism
- Formulation options for improving bioavailability
- Common formulation types
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Critical quality attributes
- In-process controls and release testing
- Clinical research
- Phases of clinical development
- Establishing safety and efficacy/bioequivalence
- Clinical study design
- Adverse event reporting
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Impact of mobile computing on clinical research
- Regulatory submissions
- The application process for chemical and biologic drug products – US and EU
- The Common Technical Document
- CTD modules
- Regional administrative information
2:30 PM – 2:45 PM Break2:45 PM – 4:15 PM
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Post-approval change
- Current situation
- Problems concerning product improvement
- New ICH Q12 – the promise of easier post-approval change
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Pharmacovigilance Important elements of regulation (US and EU)
- Drug product manufacture
- Distribution
- ICH guidance
4:15 PM – 5:00 PM Final questions, feedback and close
For more information about this training visit https://www.researchandmarkets.com/r/o0pqco
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
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