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Home » International Pharmaceutical Regulatory Affairs Professional Certification Program

International Pharmaceutical Regulatory Affairs Professional Certification Program (PRA00A1)

Certification Training
 
Rated 4.27/5
11 reviews
Duration: See individual courses below for time requirements.
Method of Training: Online / Self-paced eLearning.
Credit Hours: See individual courses located below for total credits assigned to this program.
Self-paced Training: 24/7 access to course.
Enrollment Period: 6 months.
Catalog: Pharmaceutical Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $1795.00

Document a dedication to your career and job performance by earning a professional certification from Biopharma Institute.

Biopharma Institute ReviewsTraining Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Description:

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 support@biopharmainstitute.com for more information.



Biopharma Institute LogoThe International Pharmaceutical Regulatory Affairs Professional Certification Program includes these individual courses:



Regulatory Affairs: Essentials for Human Medicinal Products - EU and US: This foundation-level training program is the ideal introduction for entrants new to the field of pharmaceutical compliance and regulatory affairs. It describes the princ | Learn more...
Duration: 3 CPD Credit Hours

Regulatory Affairs: Orphan Drug Application - EU and US: Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as 'orphan drugs' because they are commercially unattractive. Development of such | Learn more...
Duration: 1.5 CPD Credit Hours

Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format: The CTD is the internationally recognized standard format for submissions to medicines regulatory authorities. Its use is mandatory for all applications in the European E | Learn more...
Duration: 1.5 CPD Credit Hours

Regulatory Affairs: Electronic Common Technical Document (eCTD): The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory app | Learn more...
Duration: 2.5 CPD Credit Hours

Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies: This course addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requir | Learn more...
Duration: 3 CPD Credit Hours

Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US: This course outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application | Learn more...
Duration: 3.0 CPD Credit Hours

Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US: 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 succe | Learn more...
Duration: 3.5 CPD Credit Hours

Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA: The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therap | Learn more...
Duration: 0.5 CPD Credit Hours

Regulatory Affairs: The European Centralized Procedure (CP): This online course describes the procedure's various players, the duration and sequence of the stages involved, and requirements on timing, format, and content of submiss | Learn more...
Duration: 1.5 CPD Credit Hours

Regulatory Affairs: The Mutual Recognition Procedure (MRP): The Mutual Recognition Procedure is one of three routes available to applicants to gain multinational Marketing Authorization within the European Economic Area (EEA) on t | Learn more...
Duration: 2 CPD Credit Hours

Regulatory Affairs: Variations to Marketing Authorizations in Europe: Changes to the terms of marketing authorizations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authoriti | Learn more...
Duration: 3.5 CPD Credit Hours

Regulatory Affairs: The Decentralised Procedure (DCP): The DCP is one of three routes available to applicants to gain multinational marketing authorization within the European Economic Area (EEA) on the basis of a single appl | Learn more...
Duration: 2 CPD Credit Hours

Regulatory Affairs: Essentials of Monoclonal Antibodies: Monoclonal antibodies (mAbs for short) are the leading products of biotechnology. Drugs based on mAbs dominate the list of top-selling medicines worldwide. In addition, m | Learn more...
Duration: 1 CPD Credit Hours

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization

Contact Us:

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.

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