Regulatory Affairs for Pharmaceuticals, Medical Devices, and Clinical Research Training Certification Courses and Programs

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Document your dedication to regulatory affairs for pharmaceuticals, medical devices, and clinical research by earning a professional training certification from Biopharma Institute.

Choosing Biopharma Institute to provide training on regulatory affairs for pharmaceuticals, medical devices, and clinical research demonstrates the importance you place on receiving a reliable, accurate, and high-quality instruction with an emphasis on producing products or services which are safe for the consumers or patients to use. Students earning a certificate of training from Biopharma Institute have an established appreciation for regulatory and compliance and have presented a strong understanding of the subject matter taught. Below is our list of regulatory affairs for pharmaceuticals, medical devices, and clinical research training certification courses and programs.

Professional Certifications:
• Global Pharmaceutical Regulatory Affairs Professional Certification Program
• US Pharmaceutical Regulatory Affairs Professional Certification Program
• Clinical Trials Management (US & EU) Professional Certification Program
• Obtaining Approval for Clinical Trials in US & EU for Professionals
• EU MDR: EU Medical Device Regulation for Professionals
• Medical Device Single Audit Program (MDSAP) for Professionals

Subcategories (Areas of specialty or focus):

• Introduction to the Regulation of Medical Devices
• Regulatory Affairs for Human Medicinal Products (EU and US)
• MRP – The Mutual Recognition Procedure
• CTD – Preparing Submissions in the Common Technical Document Format
• eCTD – Electronic Common Technical Document
• DCP – The Decentralized Procedure
• NDA – Submitting a New Drug Application: Obtain Approval to Market in the US
• Registration of Drugs Based on Monoclonal Antibodies
• How to Gain Approval to Market Generic Drugs in the US
• The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA

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Regulatory Affairs Courses and Programs:

	Professional Certification Program: Global Pharmaceutical Regulatory Affairs Professional Certification Program Course ID: PRA00A1 Average Learning Time: See Program Webpage Price: $1795 | Learn more	Enroll Here
	Professional Certification Program: US Pharmaceutical Regulatory Affairs Professional Certification Program Course ID: PRA00B1 Average Learning Time: See Program Webpage Price: $1295 | Learn more	Enroll Here
	Individual Course w/Certificate of Completion: Regulatory Affairs: Essentials for Human Medicinal Products – EU and US Course ID: PRA01 Average Learning Time: 180 minutes Price: $225 | Learn more	Enroll Here
	Individual Course w/Certificate of Completion: Regulatory Affairs: Orphan Drug Application – EU and US Course ID: PRA02 Average Learning Time: 90 minutes Price: $145 | Learn more	Enroll Here
	Individual Course w/Certificate of Completion: Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format Course ID: PRA03 Average Learning Time: 90 minutes Price: $145 | Learn more	Enroll Here
	Individual Course w/Certificate of Completion: Regulatory Affairs: Electronic Common Technical Document (eCTD) Course ID: PRA04 Average Learning Time: 150 minutes Price: $225 | Learn more	Enroll Here
	Individual Course w/Certificate of Completion: Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies Course ID: PRA05 Average Learning Time: 180 minutes Price: $225 | Learn more	Enroll Here
	Individual Course w/Certificate of Completion: Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US Course ID: PRA06 Average Learning Time: 180 minutes Price: $225 | Learn more	Enroll Here
	Individual Course w/Certificate of Completion: Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US Course ID: PRA07 Average Learning Time: 210 minutes Price: $225 | Learn more	Enroll Here
	Individual Course w/Certificate of Completion: Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA Course ID: PRA08 Average Learning Time: 30 minutes Price: $115 | Learn more	Enroll Here
	Individual Course w/Certificate of Completion: Regulatory Affairs: The European Centralized Procedure (CP) Course ID: PRA20 Average Learning Time: 90 minutes Price: $145 | Learn more	Enroll Here
	Individual Course w/Certificate of Completion: Regulatory Affairs: The Mutual Recognition Procedure (MRP) Course ID: PRA21 Average Learning Time: 120 minutes Price: $195 | Learn more	Enroll Here
	Individual Course w/Certificate of Completion: Regulatory Affairs: Variations to Marketing Authorizations in Europe Course ID: PRA22 Average Learning Time: 210 minutes Price: $225 | Learn more	Enroll Here
	Individual Course w/Certificate of Completion: Regulatory Affairs: The Decentralized Procedure (DCP) Course ID: PRA23 Average Learning Time: 120 minutes Price: $195 | Learn more	Enroll Here
	Individual Course w/Certificate of Completion: Regulatory Affairs: Essentials of Monoclonal Antibodies Course ID: PRA24 Average Learning Time: 60 minutes Price: $145 | Learn more	Enroll Here

	Individual Course w/Certificate of Completion: Introduction to the Regulation of Medical Devices Course ID: MDA0 Average Learning Time: 60 minutes Price: $195 | Learn More	Enroll Here
	Training Program for Professionals: FDA Inspection Readiness for Professionals Course ID: FDAINSP Average Learning Time: See Program Webpage Price: $495 | Learn More	Enroll Here
	Training Program for Professionals: Medical Device Single Audit Program (MDSAP) for Professionals Course ID: MDSAP Average Learning Time: See Program Webpage Price: $1195 | Learn More	Enroll Here
	Training Program for Professionals: EU Medical Device Regulation (EU MDR) for Professionals Course ID: EUMDR Average Learning Time: See Program Webpage Price: $1295 | Learn More	Enroll Here

	Professional Certification Program: Clinical Trials Management Professional Certification Program (US & EU) Course ID: GCP00A1 Average Learning Time: See Program Webpage Price: $1295 | Learn More	Enroll Here
	Training Program for Professionals: Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals Course ID: GCP00A2 Average Learning Time: See Program Webpage Price: $895 | Learn More	Enroll Here
	Individual Course w/Certificate of Completion: Clinical Trials: Preparing for an Audit or Inspection Course ID: GCP006 Average Learning Time: 150 minutes Price: $225 | Learn More	Enroll Here
	Individual Course w/Certificate of Completion: Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USA Course ID: GCP007 Average Learning Time: 180 minutes Price: $225 | Learn More	Enroll Here
	Individual Course w/Certificate of Completion: Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU Course ID: GCP020 Average Learning Time: 180 minutes Price: $175 | Learn More	Enroll Here
	Individual Course w/Certificate of Completion: Overview of 21 CFR Part 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA) Course ID: CP015a Average Learning Time: 60 minutes Price: $199 | Learn More	Enroll Here

Online Training – The Benefits of eLearning:

• Immediate access to courses: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
• Self-paced, asynchronous eLearning: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
• Expertise: Courses have been developed by subject matter experts (SMEs) in the area of material being taught.
• Current and validated: Courses are current with respect to regulations, procedures, and are 3rd party validated and/or accredited.
• Optimized for learning: Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
• Secure and safe access: Website and LMS provide an encrypted connection, including firewall protection and daily scans for malware, to deliver optimal level of security and performance.
• Flexible final assessments: Assessments 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 requirements have been fulfilled.
• Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
• Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
• SCORM-compliant courses: Courses can be delivered directly from most corporate Learning Management Systems (LMS).
• Purchase orders (POs): POs are accepted from all companies. You must request an invoice to start the procurement process.
• Reimbursement: Some employers may reimburse their employees for training expenses. Check your company’s education reimbursement policy.
• Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. Alternatively, purchasing individual courses one at a time is also an option.
• Career advancement: Professional certifications help demonstrate interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer taking points for the interview, and practical knowledge for performing the work.

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Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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Comments: For quotes or invoices please provide the course(s) and number of students.	Regulatory Affairs for Pharmaceuticals, Medical Devices, and Clinical Research