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Saturday, June 24, 2017
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Regulatory Affairs: Registration of Monoclonal Antibodies (PRA005)

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: Registration of Monoclonal Antibodies
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

The use and production of mAbs (monoclonal antibodies) in the in-vivo diagnosis and treatment of human diseases have exponentially evolved through the years- particularly recently. This course identifies the team manufacturing concerns and issues associated with the production of monoclonal antibodies. The setting of specifications is covered as well. Requirements on clinical and preclinical studies are set out. Also described are special requirements for radio-labeled mAbs.

Procedures for making regulatory submissions for monoclonal antibodies are discussed, such as the marketing authorization application through the CP (Centralized Procedure) in Europe, and by a BLA (Biologics License Application) in the USA. Orphan drug status and its effect on clinical design are also covered. The course addresses the impact of recent developments in production techniques on the regulatory landscape, and will serve as a good source of reference all developments in the future and their practical consequences.

Once all course requirements have been satisfied, a certificate of completion is immediately available. Course takers can attempt the final assessment any number of times, as needed in order to achieve a passing grade.

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. The dinaris.org is proud to offer effective, efficient, and convenient training solutions through online courses. We serve professionals working within the healthcare, clinical research, and pharmaceutical industries. Through the years, the Institute has compiled a complete offering of training tools, such as books, recorded seminars, live seminars, online courses, and more.

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: Registration of Monoclonal Antibodies Course is Found in the Following Professional Certification Program(s):


Professional Designation in US Pharmaceutical Regulatory Affairs: … Learn more

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

COURSE OUTLINE:


Overview
This session briefly describes the regulatory pathways to licensure in the EU and US.

EU marketing approval
This session considers the regulatory requirements and pathways that are essential for marketing approval in the EU.

US marketing approval
This session considers the regulatory requirements and pathways that are essential for marketing approval in the USA.

Manufacturing issues
This session discusses key manufacturing issues in the development of mAb products.

Setting specifications
This session outlines the tests conducted and appropriate acceptance criteria or test results required to establish specifications to which a drug substance and drug product should conform to be considered acceptable for use in humans.

Preclinical issues
This session discusses key preclinical issues in the development of mAb products.

Clinical issues
This session emphasises developmental aspects crucial to the creation of safe and effective mAb products.

Radio-labelled mAbs
This session identifies the investigational studies on mAbs essential for successful marketing authorisation.

COURSE OBJECTIVES:


Students completing this course should be able to:

–Identify the regulatory requirements and pathways to licensure in the EU and USA.

–Recognize and apply the relevant studies and developmental aspects to be conducted, critical to establishing safe and effective mAb products.

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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