The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. An important use of a drug may also be discovered by accident.
For example, Retrovir (zidovudine, also known as AZT) was first studied as an anti-cancer drug in the 1960s with disappointing results. Twenty years later, researchers discovered the drug could treat AIDS, and Food and Drug Administration approved the drug, manufactured by GlaxoSmithKline, for that purpose in 1987.
Most drugs that undergo preclinical (animal) testing never even make it to human testing and review by the FDA. The drugs that do must undergo the agency’s rigorous evaluation process, which scrutinizes everything about the drug - from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured.
Why Should You Attend?
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 may squander your life 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, 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.
In this LIVE audio conference, expert speaker Angela Bazigos would lay out the whole process systematically and in a simplified manner. She will help you understand how what you do, 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 session, 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, fewer errors and much less friction between departments.
Areas covered in the session:
- 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 process
Ms Angela Bazigos,
Touchstone Technologies Silicon Valley
Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer 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 Life Sciences.
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 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
- Pharmaceutical Companies
- Biotechnology Companies
- Medical Device Companies
- Data Monitoring Companies