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Saturday, June 24, 2017
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Regulatory Affairs: Essentials for Human Medicinal Products – EU and US (PRA01)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
CPD Accredited TrainingAccreditation: This training course offers CPD accreditation from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians.
CPD Credits: 3
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $195.00

dinaris.org LogoTraining Program: Regulatory Affairs: Essentials for Human Medicinal Products – EU and US
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This foundation-level training program is the ideal introduction for entrants new to the field of pharmaceutical compliance and regulatory affairs. It describes the principal requirements needed in order to maintain and gain approval to market medicinal products in Europe and the USA. The roles of major players and legal framework are presented.

Also outlined is the life-cycle of a drug. The multiple procedures available for approval and assessment of products are described, and their requirements are discussed. Obligations which need to be filled for post-marketing approval are outlined. As changes to procedures and regulations occur, the module is updated, and therefore, serves as a good reference tool allowing not only experienced but new users to stay updated with the broader picture of the environment of regulatory affairs.

The entire program must be viewed by students in order to pass. An online, multiple-choice final assessment score of 80% or better is required. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certificate of completion is immediately available.

Benefits of Getting Certified at dinaris.org

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the dinaris.org provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The dinaris.org also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.


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.

Online Training Programs Include:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


The Regulatory Affairs: Essentials for Human Medicinal Products – EU and US Course is Found in the Following Professional Certification Program(s):


International Regulatory Affairs Professional Certification Program: This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requ … Learn more

Essentials in US Regulatory Affairs Professional Certification Program: This online professional certification program describes the essential requirements for obtaining approval of a new drug in the USA, the ‘NDA Process’. The program describes preparing submissions using the Comm … Learn more

COURSE OUTLINE:


Regulatory affairs primer

This session gives a definition of regulatory affairs and outlines the function and evolution of regulation in the pharmaceutical industry as well as providing a source of key legislation and guidelines. National and international regulatory authorities are introduced including the legal frameworks in the USA and EU.


The life-cycle of a drug

This session looks at the main differences between types of medicinal products, outlines the discovery phase and nonclinical studies and gives a basic introduction to Good Laboratory Practice. It also identifies the four phases of clinical development and introduces some of the special difficulties associated with pediatric trials.


Registering a drug

This session looks at the regulatory requirements during the nonclinical studies phase as well as the salient points of Good Clinical Practice. It also introduces the regulatory processes involved in gaining marketing authorization in the EU and the USA. The session also introduces the learner to orphan drugs, line extensions, generics, naming conventions and compassionate use.


After marketing approval
This session explores post-marketing approval activities, including variations and supplements, line extensions and pharmacovigilance, GMP, basic patent law in the EU and USA, marketing issues, advertising and generics.


Assessment

Multiple-choice mastery assessment.

COURSE OBJECTIVES:


All staff in the pharmaceutical industry who are inexperienced in regulatory affairs and compliance will find the module an invaluable introductory training course. More experienced personnel will find it a useful reference tool.

Describe the role and responsibilities of regulatory affairs within the pharmaceutical industry in both the EU and the USA.


Identify the main legislative instruments relating to medicinal products in both the EU and USA.


Understand the main phases of the drug development process and be aware of the regulatory requirements that apply.


Describe the requirements for applications for marketing approval and the procedures to be followed in both the EU and USA.


Identify post-marketing regulatory activities in both the EU and USA.

JOB POSTINGS:

313 Regulatory jobs found.
Displaying jobs #1-4.

Clinical Research Regulatory Affairs Manager
Posted Date: 2017-06-19
Medix – United States, WA, Seattle, 98127

Regulatory Compliance Analyst
Posted Date: 2017-06-19
Apex Life Sciences – United States, MD, Rockville, 20849

Regulatory Reporting Specialist
Posted Date: 2017-06-23
COOK MEDICAL – United States, IN, Bloomington, 47404

Study Start Up Regulatory Submissions Coordinator
Posted Date: 2017-06-23
Medpace – United States, OH, Cincinnati, 45208

See more Regulatory Jobs


For more information on the dinaris.org’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) 111-1111, or email Support@BioPharmaInstitute.com.

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