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(RAPro™) Global Pharmaceutical Regulatory Affairs Professional Certification Program

In an ever-increasing global market, having to sift through a myriad of disparate guidelines, mandates, and regulations can prove to be challenging. However, you still need to understand global regulations as more foreign markets are opening and marketing opportunities abound. That’s why Biopharma Institute’s (RAPro™) Global Pharmaceutical Regulatory Affairs Professional Certification Program is available. Let’s find out more about this learning program.

What is (RAPro™) Global Pharmaceutical Regulatory Affairs Professional Certification Program?

The (RAPro™) Global Pharmaceutical Regulatory Affairs Professional Certification Program is offered by Biopharma Institute.

RAPro™ courses are a renowned regulatory affairs online training that prepares you to tackle complex global regulatory compliance challenges. The training program can be taken online and you can even watch live and recorded seminars to enhance your learning experience. At the end of the course, you will be given the skills necessary to take the certification exam as well as work with global regulatory agencies. You will face no difficulties while filing submissions with foreign regulators. In addition, you will be able to conduct clinical trials overseas.

Who Should Get RAPro™ Certified?

If you want to learn how to avoid common and potential regulatory pitfalls in Japan, Europe and other regions, it is highly recommended that you enroll in the RAPro™ program and get certified when you are ready. The RAPro™ online program is ideal for individuals who need more flexibility while achieving their specific educational objectives.

Overview of RAPro™ Coursework Details

Our online Global Pharmaceutical Regulatory Affairs Professional Certification Program covers a broad range of topics. Simply select the core topics that best suit your area of responsibility.

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

Benefits of Taking the RAPro™ program at Biopharma Institute

At Biopharma Institute, you can get high quality training for all your RAPro™ program certification preparation needs. Here is a quick look at the benefits that our online platform provides:

  • Highly qualified customer service team: Our customer service team is made up of individuals who are recognized clinical research professionals. Our team can help you navigate your training and certification options so you can save money and time while en route to advanced learning.
  • Courses recognized by a broad range of industries: If you need to gain more knowledge to better contribute to your organizations, look no further than Biopharma Institute. Our online courses are recognized by the biotech industry, which provides complete peace of mind to our online course participants.
  • Convenient and flexible course formats: We understand that our course participants may be professionals working on a tight schedule. That’s why we design our training solutions to accommodate both organizational concerns and varying personal schedules.
  • Advanced eLearning tools: While you use our advanced eLearning tools to learn, don’t forget to use our automated tracking system to enhance your learning experience.
  • We cater to training projects of any size: Whether you have a training project in mind that involves 50 or 100 individuals, Biopharma Institute always has the right solution for you.

Prepare for the RAPro™ program Certification at Biopharma Institute Today!

To view our Regulatory Affairs training course catalog, click here.

For more information about our RAPro™ program online post and preparatory programs, feel free to contact the Biopharma Institute team by sending an email to or calling (888) 424-6576.