Student Login |


Wednesday, April 26, 2017
Home » Online Training Course

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

Description: This program includes registration of monoclonal antibodies, essentials for human medicinal products in EU and US, orphan drug application in EU and US, preparing submissions in the common technical document (CTD) form, electronic common technical document (eCTD), the ANDA, requirements for obtaining FDA approval for a generic product in the USA, the NDA process, requirements for obtaining approval for a new drug in the USA, the European centralized procedure (CP), the mutual recognition procedure (MRP), EU variations procedure, and the decentralized procedure (DCP).
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

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



Regulatory Affairs: Registration of Monoclonal Antibodies: The production and use of monoclonal antibodies (mAbs) in the in-vivo diagnosis and treatment of human diseases has evolved exponentially in recent years. This module identifies the key manufacturing issues and the concerns associated with mAb production. Setting of specifications is also discussed. Requirements on preclinical and clinical studies are set out. Special requirements for radio-labelled mAbs are described. Procedures for making regulatory submissions for mAbs are detailed: marketing authorisation application through the Centralised Procedure (CP) in Europe, and by a Biologics License Application (BLA) in the USA. Orphan drug status and its effect on clinical design are addressed. The module discusses the impact of recent developments in production techniques on the regulatory landscape and will serve as an effective reference source on future developments and their practical consequences.

Regulatory Affairs: Essentials for Human Medicinal Products – EU and US:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

This foundation-level module 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 module 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.

Regulatory Affairs: Orphan Drug Application – EU and US:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

Orphan drugs are those for relatively rare indications. Special procedures and incentives apply to their registration, to encourage pharmaceutical companies to develop them. This module provides information necessary to enable the preparation of applications for orphan drug status in the EU and USA. The procedures for making an application are detailed, including the collection of supporting data and the acquisition of protocol assistance. In Europe the Centralised Procedure is now the mandatory route to gain marketing authorisation for orphan products. This module will serve as a useful reference tool to keep abreast of the impact of the new regulatory requirements.

Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

The CTD is the mandatory format for regulatory submissions in the European Union, Japan, Canada and Australia and strongly recommended in the USA. It is accepted widely elsewhere. This module explains the rationale for the CTD and provides detailed guidance on its structure and format. Related documents such as Drug Master Files and Certificates of Suitability are also dealt with.

Regulatory Affairs: Electronic Common Technical Document (eCTD):
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of registration dossiers. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module details the eCTD specifi cation, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. This relatively new aspect of submissions will undergo rapid and signifi cant change as specifi cations are modifi ed and refi ned further. The eCTD module is an excellent reference and training tool and will assist anyone involved with electronic submissions in navigating these changing requirements.

Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

This course describes FDA expectations of applications for the licensing of generic products. It provides the background knowledge to effectively plan, gather and assemble the necessary documentation for the submission of an Abbreviated New Drug Application (ANDA). Practical advice in the form of checklists is provided, and timelines are set out. The ANDA process is compared and contrasted with that for the NDA.

Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

A New Drug Application (NDA) is a regulatory vehicle through which Sponsors formally propose that the FDA approve a new drug for sale and marketing in the USA. For successful FDA approval, what content and format requirements are necessary to comply with FDA guidelines? How do you plan your submission timetable? This module provides regulatory professionals with the requirements to complete and submit NDAs for FDA approval.

Regulatory Affairs: The European Centralised Procedure (CP):
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

The CP is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA). In the CP, one successful application leads to a licence being issued by the European Commission that applies throughout the EEA. The CP is mandatory for certain types of products. This module describes the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions.

Regulatory Affairs: The Mutual Recognition Procedure (MRP):
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

The Mutual Recognition Procedure is one of three routes available to applicants to gain multinational Marketing Authorisation within the European Economic Area (EEA). A national licence is converted to harmonised licences issued in a number of other member states chosen by the applicant. The MRP is similar to the Decentralised Procedure but with later involvement of the Concerned Member States in the assessment by the Reference Member State. The Coordination Group for Mutual Recognition and Decentralised Procedures provides guidance and acts to facilitate agreement among the participating states. This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the MRP.

Regulatory Affairs: EU Variations Procedure:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

Regulatory authorities must approve any variation to the terms of a marketing authorisation. Common approaches are adopted within the European Economic Area to variations to licences approved through the Centralised, Decentralised or Mutual Recognition Procedures. For national licences, each country applies its legislation and guidelines. This module details the legislation and classifi cations for variations and will enable the learner to submit variations applications for products authorised through any of the three multinational procedures. It describes how to identify the type of application required, the procedures to follow, the timelines, and the data required for a submission.

Regulatory Affairs: The Decentralised Procedure (DCP):
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

The DCP is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA). It can be used only for a product which has no existing marketing authorisation in any member state. It is similar to The Mutual Recognition Procedure (MRP) but with earlier involvement of the Concerned Member States in the assessment by the Reference Member State. The Coordination Group for Mutual Recognition and Decentralised Procedures (CMD) provides guidance and acts to facilitate agreement among the participating states. This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the DCP.


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.

Information Request / Suggest a Course Form:

NAME:
COMPANY:
ADDRESS:
CITY:
STATE:
ZIP CODE:
COUNTRY:
PHONE:
EMAIL:
 
Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us
with as much detail as possible about your training project):