home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Meetings and Conferences
Search
 
 

The Drug Development Process from Concept to Market

  
  May 24, 2021
Medical Research (others)
  
     
 
ComplianceOnline, Virtual Training Through WebEx
2021-07-27

DAY 01(10:00 AM - 5:00 PM EDT)
  • 10:00 AM -11:00 AM
    •  
      • Size and key therapeutic areas
      • Regional differences
      • Market shares of chemical and biological drugs
      • Roles of drug development professionals
      • Product types and routes of administration
      • The drug development process
      • Risks in drug development
      • Drug targets
      • The Human Genome Project
      • Lead compound identification and optimization
      • The global pharmaceutical marketOverview – development of drug productsDrug discovery
  • 11:00 AM -11:15 AM Break
  • 11:15 AM -12:00 NOON
    •  
      • Drug plasma concentration profiles
      • Absorption, distribution, metabolism and elimination of drugs
      • First-pass metabolism
      • Types of toxicity screening
      • Pharmacokinetics and toxicity
  • 12:00 NOON -1:00 PM Lunch
  • 1:00 PM -2:00 PM
    •  
      • 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
      • Phases of clinical development
      • Establishing safety and efficacy/bioequivalence
      • Clinical study design
      • Adverse event reporting
      • Impact of mobile computing on clinical research
      • The application process for chemical and biologic drug products – US and EU
      • The Common Technical Document
      • CTD modules
      • Regional administrative information
      • Pre-clinical developmentClinical researchRegulatory submissions
  • 2:30 PM - 2:45 PM Break
  • 2:45 PM - 4:15 PM
    •  
      • Current situation
      • Problems concerning product improvement
      • New ICH Q12 – the promise of easier post-approval change
      • Drug product manufacture
      • Distribution
      • ICH guidance
      • Post-approval changePharmacovigilance Important elements of regulation (US and EU)
  • 4:15 PM - 5:00 PM Final questions, feedback and close
  
 
Organized by: ComplianceOnline
Invited Speakers: 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.
 
Deadline for Abstracts: 2021-07-25
 
Registration:
$1,099*
(Seminar for One Registration)
July 27, 2021, Virtual Seminar

Register now and save $400 (Actual Price: $1,499)
E-mail: referral@complianceonline.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.