Introduction
Course Type
Course Duration
Eligibility
Who should attend
Certification
Features
Related Courses
About RA
The US regulatory affairs certification training course is to train pharmaceutical, biopharmaceutical regulatory approval process in US. The course provide comprehensive training on fundamental regulatory topics. For example, understanding about investigational new drug, and biologics development and approval process, submission dossier preparation, filing steps etc. Moreover, upon completion of the fundamental section, you will move to the next level which is advance strategic planning on portfolio management. Hence, this course is ideal for the effective training of Regulatory Affairs personnel. Above all, this US Regulatory Affairs training course gives practical knowledge and real life job simulation. Course focus on how regulatory professionals work in company and understanding of key responsibilities and job functions.
This is online self-paced modules. Therefore participant can attend the course at it’s own convenient time 24×7.
Course Code: RYD-014
Course Title: Advance Certification in USFDA pharmaceutical and Biopharmaceutical Regulatory Affairs
Online distance learning certification course. So, course can be accessed online across anywhere 24×7.
1 Month.
Graduation in any discipline.
Who should attend this course?Â
- Anyone wishing to update their knowledge on US regulatory affairs knowledge for biopharma and biosimilars.
- Regulatory Affairs, Registration and Documentation assistants, officers or managers.
- Those who are in regulatory affairs and related department.
- Likewise, professionals from drug discovery development.
- Fresher or beginners, Those who want to make a career in drug regulatory department. Therefore, seeking advance understanding on US regulatory affairs.
- This course is also ideal for the Biopharmaceutical professionals seeking to improve their skills in the US regulatory environment.
Certificate will be provided at the end of the successful completion of the course
Course Features
The participant will be understanding about the US pharmaceutical and biopharmaceutical development to commercialization process in detail. Course is divided into two phases.
Phase 1 – US Pharmaceutical Regulatory Affairs
Phase 1 focus on the detail training on US regulatory approval of drugs (chemical small molecules). It covers stages of drug discovery and development, investigational new drug application, new drug application, handling of different phases of clinical trial, generic drug approval process, Abbreviated new drug applications. Course covers fundamental to advance learning on drug development, regulation, registration and strategic management process.
Phase 2 – US Biopharmaceutical Regulatory Affairs
Phase 2 focus on the detail training on US regulatory approval of biopharmaceuticals. Further, course is divided into innovator biologics regulation and biosimilar regulation. It covers stages of biologic license application process and approval pathway, biosimilar development and approval pathway. Course covers fundamental to advance learning on biomanufacturing, process development, regulation, registration. Above all, course is containing specialized on biologic strategic portfolio management.
Other important features to note:
- Course provide orientation to job related practical aspects of the drug regulatory managers.
- Simulation to real life working in regulatory affairs department. It help to enhance the regulatory strategic decision making.
- Advance training on drug registration requirements for various regulatory bodies.
- Access to Case Studies to learn about the drug registration steps.
Few of the similar courses
Career in Drug Regulatory Affairs. How US regulatory affairs certification helps?
A career in Regulatory Affairs is very challenging, but highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.
The United States pharmaceutical and biopharmaceutical industry is growing at a rapid pace. As far as regulatory is considered, US is considered to be the highly regulated market. Therefore, pharma regulations and laws are changing or getting updated in quick span of time. Hence, it is important for participant to know and update their knowledge periodically.
One more important thing to note here. In recent times there is a rising concern over the safety and efficacy. US regulators even found to be busy auditing plants and lot of 483 observations and warning letters are issued across globe for manufacturing companies. Hence, course participant requires advance training on warning letter, 438 observations.
Lastly, “Data Integrity” is the latest buzz word. Lot of data integrity issues leads to 483s or even warning letters. In fact, more than 30
% of the warning letters are due to data integrity. Regulatory professionals should know what is data integrity and how to handle the data integrity issues.
In conclusion, this US regulatory certification course trains the candidate on not only on drug and biologic registration and regulation, it covers all important recent aspects. For example, course includes how to handle USFDA warning letter, 483 observations, data integrity issues, etc.
About regulatory affairs job>> Learn here
