Live Webinar Drug Discovery & Development: the FDA Way
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
"Hear By Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"
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.
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.
- 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
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 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
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel