Duration: 2 hours, Online (the average time to complete the training program, including final assessments).Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.
Training Program: Pharmaceutical Regulatory Affairs: Essentials for Human Medicinal Products - EU and US
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment. This foundation-level course is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed. When changes to regulations and procedures occur, The course is updated and hence serves as a handy reference tool allowing new as well as experienced users to keep up to date with the broader picture of the regulatory affairs environment.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
The Pharmaceutical Regulatory Affairs: Essentials for Human Medicinal Products - EU and US course is found in the following professional certification program(s):
Introduction: This session looks at issues which have to be considered when developing Orphan Products in the EU and USA, including the costs of development, development risks, advantages of orphan status, how to obtain advice and strategy for orphan applications.
Orphan medicinal products in the EU: This session looks at the role of the EMEA and COMP, the definition of an orphan product, how to apply for orphan designation, supporting data required, and the approval process including refusal and the appeal procedure.
Orphan medicinal products in the USA: This session looks at the role of the FDA's OOPD, the definition of an orphan product, how to apply for orphan designation, supporting data required, and the approval process including refusal and the appeal procedure.
Students completing this course should be able to: Describe the advantages of orphan drug status in the EU and USA. Explain how to prepare applications for orphan drug designation in the EU and USA. Understand the approval process for orphan designation in the EU and USA and how to proceed if orphan designation is refused.
Online Training Program Benefits:
- Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
- Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
- Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
- Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
- Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
- Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization
For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.