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Thursday, June 22, 2017
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International Regulatory Affairs Professional Certification Program (PRA00A1)

Certification Training Duration: 20 hours (the average time to complete the training program, including final assessments).
Credits Hours: 20
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $1995.00


This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requirements for obtaining approval for a new drug in the USA (the NDA process) and for obtaining FDA approval for a generic product in the USA (the ANDA); electronic common technological document (CTD); preparing submissions in the common technical document (CTD); orphan drug application in the US and EU; essentials for human medicinal products in US and EU; and registration of monoclonal antibodies.

Students participating in this program will be required to take the following Regulatory Affairs courses which are included within the program: 1) The Decentralized Procedure (DCP); 2) EU Variations Procedure; 3) The Mutual Recognition Procedure (MRP); 4) The European Centralized Procedure (CP); 5) The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA; 6) The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA; 7) Electronic Common Technical Document (eCTD); 8) Preparing Submissions in the Common Technical Document (CTD) Form; 9) Orphan Drug Application- EU and US; 10) Essentials for Human Medicinal Products- EU and US; and 11) Registration of Monoclonal Antibodies.

Once all course requirements have been satisfied, a professional certification is immediately achieved.

Benefits of Getting Certified at BioPharma Institute

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. The BioPharma Institute has proudly provided online training solutions for two decades and assisted individuals from thousands of corporations both abroad and in the United States. Find out what we at the BioPharma Institute can do for your colleagues, you, and/or your employees to further or refresh regulatory education in the biotechnology, pharmaceutical, and healthcare industries.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at for more information.

Training Provided By: BioPharma Institute

BioPharma Institute LogoThe International Regulatory Affairs Professional Certification Program Includes the Following Individual Courses:

Regulatory Affairs: Registration of Monoclonal Antibodies: 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 class identifies the tea … Learn more

Regulatory Affairs: Essentials for Human Medicinal Products – EU and US: This foundation-level module is the ideal intro for entrants new to the field of pharmaceutical compliance and regulatory affairs. It describes the principal requirements needed in order to maintain and gain ap … Learn more

Regulatory Affairs: Orphan Drug Application – EU and US: Orphan drugs are those for relatively rare indications. Special incentives and procedures apply to their registration to encourage the development of them by the pharmaceutical companies. This class provides in … Learn more

Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form: The Common Technical Document is the mandatory format for regulatory submissions in Australia, Canada, Japan, the European Union, and, for the United States of America, it is strongly recommended. It is widely … Learn more

Regulatory Affairs: Electronic Common Technical Document (eCTD): The Electronic Common Technical Document specification has been developed to facilitate the lifestyle management, review, and the global electronic submission of registration dossiers. It broadens the scope of … Learn more

Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA: This course discusses FDA expectations of applications for generic product licensing. It provides the background knowledge to effectively assemble, gather, and plan the necessary documentation in order to submi … Learn more

Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA: An NDA (New Drug Application) is a regulatory vehicle through which sponsors formally propose that the FDA approve a new drug for marketing and sale in the USA. For successful STA approval, what format and cont … Learn more

Regulatory Affairs: The European Centralised Procedure (CP): The class describes the procedure’s various players, the duration and sequence of the stages involved, and requirements on timing, format, and content of submissions. In the Centralized Procedure, one successfu … Learn more

Regulatory Affairs: The Mutual Recognition Procedure (MRP): The class discusses the special issues that are found when dealing with generic products in the MRP. Facilitating agreements among participating states, the Coordination Group for Mutual Recognition And Decentr … Learn more

Regulatory Affairs: EU Variations Procedure: All variations to a marketing authorization’s terms must be approved by regulatory authorities. Within the European Economic Area, common approaches are adopted to variations to licenses approved through the Mu … Learn more

Regulatory Affairs: The Decentralised Procedure (DCP): This course describes specific issues that apply to generic products in the Decentralized Procedure. It also discusses the requirements on timing, formats, and content of submissions as well as the roles of the … Learn more

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

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