DUBLIN–(BUSINESS WIRE)–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 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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