Mark Powell, Director

Mark Powell Scientific Limited

Course Description

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

Agenda

DAY 01(10:00 AM - 5:00 PM EDT)

10:00 AM -11:00 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

11:00 AM -11:15 AM Break

11:15 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
  • Distribution
  • ICH guidance

4:15 PM - 5:00 PM Final questions, feedback and close

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

In Partnership with Compliance Online

Mark Powell

Mark Powell


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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$1,299

One Dial-in One Attendee

October 22, 2020, Virtual Seminar

Registrations till September 10, 2020 - $1299

Registrations after September 10, 2020 - $1599

$6,625

Group-Max. 10 Attendees

October 22, 2020, Virtual Seminar

Registrations till September 10, 2020 - $6625

Registrations after September 10, 2020 - $7795