Accredited by IACET/ANSI
This certificate course will introduce you to what regulators look for when drugs for rare diseases are submitted for approval. The course covers the most effective routes for drug development in rare diseases. You will learn about the FDA approaches to the challenging aspects of drug development in the rare disease space with examples of rare drug development. You will also learn about expedited programs for drugs that address the serious and life-threatening aspects of rare diseases. You will discover priority review vouchers and how they applies to rare diseases.
4.6 | (500 + Graduates)
1 Modules
6 Months Access
100% Online & Self Paced
24/7 Live Chat
Total Price : $3718.98
Buy all together : $ 3718.98
Rare Disease Drug Approval
Learn the FDA’s approaches to the drug development challenges in the rare disease space.
Expedited programs
Identify the details about expedited programs for drugs that address the serious and life-threatening aspects of rare diseases.
Priority Review
Discover priority review vouchers and how this applies to rare diseases.
Orphan Drug Act of 1983
Impact of Orphan Drug Act of 1983 on Drug Development for Rare Diseases and public health impact.
Users
Countries
Companies
Module 1
This course introduces you to what regulators look for when rare disease drugs are submitted for approval. The course covers the FDA’s approaches to the drug development challenges in the rare disease space. Identify the details about expedited programs for drugs that address the serious and life-threatening aspects of rare diseases. Discover priority review vouchers and how this applies to rare diseases.
4.6 | (500 + Graduates)
Value For Money
4.6/5
Easy to Navigate
4.7/5
Program Content
4.7/5
Reviews Mention
The program was easy to follow and informative. It helped me to better understand the industry as a whole and the opportunities to grow in that field.
The program was very informative and provided an excellent perspective. In addition, it complemented and confirmed my acquired knowledge in the Medical Affairs environment.
It is an enriching Medical Affairs program with extremely positive impact on daily job
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