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
Chief Compliance Officer ,
Angela, is the Chief Compliance Officer of Morf Media. She has 40 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & Software Validation.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.
More recently, Ms Bazigos was quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom click here and is working with the FDA to define those metrics that will be used for compliance at the Boardroom level. She is also assisting the FDA with updating their guidance “General Principles of Software Validation” (published in 2002).
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