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

---

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 train on how to maintain regulatory affairs for pharmaceuticals, medical devices, and clinical research compliance demonstrates your high priority on preserving quality and consumer protection. Employees earning a certificate of training from Biopharma Institute have established their value and understanding for 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:

• 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

---

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 training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
• Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
• Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
• Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
• Optimized for learning: Courses include voiceovers, easy navigation, 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 with firewall protection and daily scans for malware to deliver optimal level of security and performance.
• Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
• Purchase orders (POs): If issuing 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.
• Reimbursement: Some employers may reimburse for training expenses. Check your company’s training reimbursement policy.
• 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.
• Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
• Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
• 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.

---

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.

Name:
Company:
Phone:
Email:
Enter the number from the image above:
Comments: For quotes or invoices please provide the course(s) and number of students.	Regulatory Affairs for Pharmaceuticals, Medical Devices, and Clinical Research