The Drug Development Process from Concept to Market (com) A

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Philadelphia, PA 19019

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The Drug Development Process from Concept to Market

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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

Seminar Fee Includes:


AM-PM Tea/Coffee

Seminar Material

USB with seminar presentation

Hard copy of presentation

Attendance Certificate

$100 Gift Cert for next seminar

Who will Benefit:

  • Non-scientific employees of pharmaceutical companies who would like to understand how drugs are developed (e.g. IT, human resources, engineering and administrative staff)
  • Recently-appointed scientific staff with no previous experience of the pharmaceutical industry
  • Any pharmaceutical employee wishing to improve their knowledge of drug development


DAY 01(8:30 AM - 4:30 PM)

9:00 AM -10:00 AM

The global pharmaceutical market

Size and key therapeutic areas

Regional differences

Market shares of chemical and biological drugs

Roles of drug development professionals

Overview – development of drug products

Product types and routes of administration

The drug development process

Risks in drug development

Drug discovery

Drug targets

The Human Genome Project

Lead compound identification and optimization

10:30 AM -10:45 AM Break

10:45 AM -12:00 NOON

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 Lunch

1:00 PM -2:00 PM

Pre-clinical development

Polymorph and salt form screening

Solubility, permeability and oral bioavailability

Optical isomerism

Formulation options for improving bioavailability

Common formulation types

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

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 Break

2:45 PM - 4:15 PM

Post-approval change

Current situation

Problems concerning product improvement

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

Pharmacovigilance Important elements of regulation (US and EU)

Drug product manufacture


ICH guidance

4:15 PM - 4:30 PM Final questions, feedback and close


Mark Powell

Director, Mark Powell Scientific Limited

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

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