ComplianceOnline

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

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-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Mark Powell

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.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,699.00

(One Dial-in One Attendee)

October 22, 2020, Virtual Seminar

$8,665.00

Group-Max. 10 Attendees

October 22, 2020, Virtual Seminar



Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Note: In view of Coronavirus situation and travel advisory issued, ComplianceOnline will waive off all cancellation charges for the registrations till September 30, 2020.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions for In-person Seminars:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
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