Drug Development & Discovery by FDA Standards

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Description:

The Drug Discovery and Development (but also the biologics and medical device) process is a very complex process with every participant focusing on their particular piece of discovery or development. You can spend a lifetime in your part of the process, without ever understanding the complete picture. While you may hear or see the other parts by interacting with colleagues from other parts of the process you never quite get the whole picture. Add to that, that different regulatory agencies have different requirements and it often feels like pieces of a jigsaw puzzle which you see at random, never quite understanding how they all fit together to get the big picture.

This leaves you confused, causes friction between departments and leaves the company prone to errors and mishaps that can be avoided if you understood what the other parts of the company and an FDA inspector require of you. This in turn results in delayed timelines, product recalls and operational inefficiencies.

This webinar will lay out the whole process systematically and in a simplified manner. It will help you to understand how what you do and your goals and objectives, contribute to the overall success of the company, both in terms of product approval by the FDA or in terms of successful inspection outcomes. At the end of the webinar, you will be able to have better communication with your functional colleagues and the quality and regulatory affairs departments. This will lead to higher quality product, easier approvals, many fewer errors and much less friction between departments. It is a must for anyone that is either joining the Pharmaceutical / Biotechnology / Medical Device industries for the first time, or anyone that is transferring from one part of the company to another part (e.g. from discovery to development and vice versa). Also for international attendees that need to familiarize themselves with the FDA process and how it differs from other regulatory authorities.

Areas to be Covered:

  • Stages of Drug Development and Review
  • Drug Review Steps Simplified
  • Reviewing Applications
  • Accelerated Approvals
  • Bumps in the Road
  • The Role of User Fees
  • The Quality of Clinical Trials
  • How Drugs are Approved
  • How does the FDA differ from other regulatory authorities
  • Frequently Asked Questions about the FDA Drug Approval Proces

Who will Benefit:

This is a fundamental course that will benefit the following people:

  • Anyone that works or plans to work in Pharmaceutical, Biotechnology or Medical Device Industries will benefit.
  • Anyone that is already working in the above industries, but is transferring from one part of the industry to another part (e.g. transferring from discovery to development of vice versa)
  • Anyone that works in companies that support the above industries e.g., IRBs, CROs, Data Monitoring Companies
  • International attendees that may be familiar with the above process in their country and for their regulatory authorities, but wants to learn the process as expected by the FDA

Angela Bazigos

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences.

membership
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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance