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The Drug Development Process from Concept to Market Training Course


Location: California, USA
From: 2021/06/13 10:00
To: 2021/07/15 14:30
Posted by: WCS Compliance

About this event
Learn Drug Development Process from Concept to Market

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

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

Break

Pharmacokinetics and toxicity

  • Drug plasma concentration profiles
  • Absorption, distribution, metabolism and elimination of drugs
  • First-pass metabolism
  • Types of toxicity screening

Break

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

Break 15 mins

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

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
Faculty Karl M. Nobert (25+ yrs exp)

Senior Counsel Michael Best & Friedrich LLP - USA

Karl focuses his practice in FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages including dairy products, cosmetics, vitamins and dietary supplements, and veterinary products.

He has particular experience in the areas of prescription drugs and regenerative medicine, and has counseled numerous clients seeking FDA approval for Rx drugs and cellular-based products to treat both humans and animals.

Our Past Seminar Testimonial

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals




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