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  Pharmaceutical Regulatory Affairs: Training & Certification Programs
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BioPharma Institute Online Training Course Catalog


 

 

Pharmaceutical Regulatory Affairs

Pharmaceutical Regulatory Affairs Training and Professional Designation Programs

BioPharma Online Training Programs include;

  1. 24/7 access to the courses for a 90 day (3 month) period OR 270 days (6 months) for Professional Designation Programs,
  2. A printable PDF file including the course notes (not available with all courses),
  3. An online, multiple-choice final assessment, and
  4. A Certificate of Completion, which is immediately available once the course requirements have been satisfied (a Certificate of Professional Designation is issued once all requirements are filled for a Professional Designation program).
  5. LIVE WEBINARS ONLY: For live webinars, enrollees have access to the live webinar presentation. The recorded version and literature is available to the enrollee for one full year.

Certification Training Professional Designation in US Pharmaceutical Regulatory Affairs Comprehensive Training Program
Professional Designation in US Pharmaceutical Regulatory Affairs - PRA000S1
PRICE: $1295 |
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Certification Training Pharmaceutical Regulatory Affairs: Essentials for Human Medicinal Products - EU and US Pharmaceutical Regulatory Affairs: Essentials for Human Medicinal Products - EU and US - PRA001
PRICE: $199 |
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Certification Training Pharmaceutical Regulatory Affairs: Orphan Drug Application - EU and US Pharmaceutical Regulatory Affairs: Orphan Drug Application - EU and US - PRA002
PRICE: $199 |
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Certification Training Pharmaceutical Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form Pharmaceutical Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form - PRA003
PRICE: $199 |
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Certification Training Pharmaceutical Regulatory Affairs: Electronic Common Technical Document (eCTD) Pharmaceutical Regulatory Affairs: Electronic Common Technical Document (eCTD) - PRA004
PRICE: $199 |
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Certification Training Pharmaceutical Regulatory Affairs: Registration of Monoclonal Antibodies Pharmaceutical Regulatory Affairs: Registration of Monoclonal Antibodies - PRA005
PRICE: $199 |
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Certification Training Pharmaceutical Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA Pharmaceutical Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA - PRA006
PRICE: $199 |
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Certification Training Pharmaceutical Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA Pharmaceutical Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA - PRA007
PRICE: $199 |
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Certification Training Pharmaceutical Regulatory Affairs: The European Centralized Procedure (CP) Pharmaceutical Regulatory Affairs: The European Centralized Procedure (CP) - PRA020
PRICE: $199 |
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Certification Training Pharmaceutical Regulatory Affairs: The Mutual Recognition Procedure (MRP) Pharmaceutical Regulatory Affairs: The Mutual Recognition Procedure (MRP) - PRA021
PRICE: $199 |
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Certification Training Pharmaceutical Regulatory Affairs: EU Variations Procedure Pharmaceutical Regulatory Affairs: EU Variations Procedure - PRA022
PRICE: $199 |
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Certification Training Pharmaceutical Regulatory Affairs: The Decentralized Procedure (DCP) Pharmaceutical Regulatory Affairs: The Decentralized Procedure (DCP) - PRA023
PRICE: $199 |
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View training courses by category:
Regulatory Affairs | Medical Devices | Good Clinical Practice | Good Manufacturing Practice | Good Laboratory Practice | Validation for BioPharma | IT/IS for BioPharma | 21 CFR Part 11 | Pharmacovigilance | GMP Employee Training | Biotechnology | Genetic Identity and Inheritance | Social Media for Healthcare

View webinars by category:
FDA GXP Compliance - Pharmaceuticals | Laboratory Compliance | Clinical Compliance | 21 CFR Part 11 Compliance | Food Safety Compliance ISO 22000 HACCP | FDA Validation | Biotech | OSHA Health and Safety Compliance | Trade And Logistics Compliance | FDA GXP Compliance - Medical Devices | FDA Compliance | HR Compliance | Quality Management and ISO 9000 | HIPPA Compliance | Financial and Accounting Compliance | Corporate Governance Ethics Board Management | SEC Compliance | Clinical Research | FDA Documentation | IT Controls and Compliance | Social Media for Healthcare


View books by category:
Biotechnology Books | Clinical Research Books | Medical Device Books | Regulatory Books | Pharmaceutical Books | Validation Books


Types of Training Offered From the BioPharma Institute:

Live, In-person Training: The acquisition of knowledge, skills, and competencies as a result of having a live, in-person instructor is a wonderful way to train employees. However, the cost involved, the inconsistency of formats, and variety of quality among teachers all contribute to the extreme variability in its performance. Many companies spend lots of money providing unsuccessful training to its employees. At the BioPharma Institute we have a pool of live, in-person, instructors with proven experience delivering high-quality and effective training.

Computer-based Training: The activity of imparting and acquiring skills through training provided via computer, either offline or through the Internet, allows the trainee to learn at their own pace and review topics more than once through illustrations, reading text, and listening to online seminars. This can be a very effective, time- and cost-efficient, method of training. By incorporating progress checks, problem solving, case studies, and mnemonic learning aids, this form of training can be extremely successful. At the BioPharma Institute we have made computer-based training our expertise. We are proud to offer our SME-developed content and proven experience delivering high-quality and effective computer-based training to pharmaceutical and biotechnology companies around the world.

Blended Training: Blended Training incorporates both, Live, In-person Training with supplemented Computer-based training. This method allows for the added assurance that preparation for training has been performed by all learners. Many companies are now resorting to blended training to increase the performance of their training activities. At the BioPharma Institute, we have experience assisting companies with developing and implementing this activity into their delivery.



For more information on Pharmaceutical Regulatory Affairs or the BioPharma Institute's other 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) 800-4430, or email Support@BioPharmaInstitute.com.

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