Investigational New Drug, IND Review, Basic for INDA, USFDA regulations, FDA Meetings, Non-clinical study, Updating INDA
Description
Developing New Drugs
you can create new job opportunity for your additional skills and get Jobs as new profile in Pharma industry in Regulatory department. Add on skills may enhance chances for selection in interviews, New knowledge for updation.
This course will gives insights on Investigational New Drug, IND Review, Basic for INDA, USFDA regulations, Non-clinical study overview, Updating INDA
The research center’s best-known job is to evaluate new drugs before they can be sold. CDER’s evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.
Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s data and proposed labeling. If this independent and unbiased review establishes that a drug’s health benefits outweigh its known risks, the drug is approved for sale. The center doesn’t actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.
Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it’s likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.
Drug development and approval process:
The mission of FDA’s Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. CDER does not test drugs, although the Center’s Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness.
Some companies submit a new drug application (NDA) to introduce a new drug product into the U.S. Market. It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the sponsor’s NDA containing the data and proposed labeling.
Application Types
- Investigational New Drug (IND) Application
- New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- Therapeutic Biologics Applications (BLA)
- Drug Applications for Over-the-Counter (OTC) Drugs
Course eligiblity:
- Doctors and medical background students
- Any life-sciences background are eligible.
- Pharmacy Students and professionals (Ph.D, M.Pharma, B.pharma)
- Regulatory affairs from Pharma industry can add on Skills in there profile
Benefits of course:
- Know about IND application and review process
- USFDA regulations for INDA
- Add on skills in professionals profile
- Grab new knowledge and updates
- Avail/Create New job opportunities in regulatory affairs
Prerequisites: No prerequisites required, only need curiosity towards learning and science background.
Achivements after course:
- Certificate of completion.
- Add on skill.
- You can update your professional profile.
- New job opportunities in research.
- Life time access to course.
- Upgrade your skills and knowledge in clinical research.
Who this course is for:
- Pharmacy students
- Master of pharmacy
- Bachelors of pharmacy
- Pharma professionals
- Regulatory affairs professional
- Any lifescience educational background
- New job seekers in Regulatory affairs
