Online Course in Drug Development: The Key to Success, From Concept to Commercialization – October 17-18, 2022 –

DUBLIN–(BUSINESS WIRE)–Training “Drug Development: The Key to Success, from Design Course to Commercialization” has been added to from offer.

The course begins by reviewing 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 course includes drug target identification, chemical drug synthesis and biologics development, pharmacokinetics and toxicity screening, preclinical development, clinical studies, regulatory submissions, post-approval change management , pharmacovigilance and an overview of the regulations governing the manufacture of medicines. and dissemination.

The drug development process, from discovery to post-marketing surveillance, is then explained. This course is designed to teach pharmaceutical company employees who wish to understand 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 the development process

  • Factors Affecting Oral Bioavailability

  • The size of the global pharmaceutical market and the main therapeutic areas addressed by innovative 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 Safety and Efficacy of Pharmaceuticals are Ensured During QC Release Testing

  • Information obtained at each stage of clinical research

  • How are post-approval changes to pharmaceutical products handled?

  • How the manufacture and distribution of marketed drugs are controlled

Who should attend:

  • Non-scientific employees of pharmaceutical companies who want to understand how drugs are developed (for example, IT, human resources, engineering and administrative staff)

  • Recently appointed scientific staff with no previous pharmaceutical industry experience

  • Research and development scientists

  • Clinical Research Associates

  • Auditors

  • Regulatory Affairs Professionals

  • CMC/Pharmaceutical Research Professionals

  • Regulatory Affairs Professionals

  • Project managers

  • Financial managers

  • Brand team staff

  • Senior Sales Managers

  • Strategic planners

  • Quality assurance staff

  • Manufacturing staff

  • Medical and clinical investigators

  • Statisticians and Data Management Professionals

  • Any pharmaceutical employee wishing to deepen their knowledge in drug development

Main topics covered:

Overview of Drug Development Products

  • Types of products and routes of administration

  • The drug development process

  • Drug Development Risks

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

  • Identification and optimization of lead compounds

Regulatory submissions

  • The Common Technical Document

  • CTD modules

  • Regional administrative information

  • The Application Process for Chemical and Biological Drugs – US and EU

Preclinical development

  • Optical isomerism

  • Formulation options to improve bioavailability

  • Common Formulation Types

  • Critical Quality Attributes

  • In-process checks and version testing

  • Screening for polymorphic and saline forms

  • Solubility, permeability and oral bioavailability

Clinical research

  • Design of clinical studies

  • Clinical development phases

  • Establish safety and efficacy/bioequivalence

  • Declaration of adverse events

  • Impact of Mobile Computing on Clinical Research

Pharmacokinetics and toxicity

  • Plasma Drug Concentration Profiles

  • Absorption, distribution, metabolism and elimination of drugs

  • First pass metabolism

  • Types of Toxicity Screening

Post-approval change

  • Product improvement issues

  • New ICH Q12 – the promise of easier post-approval change

  • Current situation

American and European pharmacovigilance Important elements of the regulations

  • Manufacture of pharmaceutical products

  • Distribution

  • ICH Guidance

Last questions, comments and conclusion

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