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      The Drug Development Process from Concept to Market in Philadelphia

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      September 16, 2020

      Wednesday   8:30 AM - 4:30 PM (daily for 1 times)

      Philadelphia, Pennsylvania 19019

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      The Drug Development Process from Concept to Market

      The Drug Development Process from Concept to Market
      About this Event


      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.

      Cost: $1,799

      Categories: Conferences & Tradeshows

      This event repeats daily for 1 times:

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.

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