Rare Disease Drug Development Course

Certificate Course
|
IACET Logo

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)

$719.99
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1 Modules

6 Months Access

100% Online & Self Paced

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Frequently Bought Together

Learning Objectives

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.

Master These Skills

Rare diseases
Drug development
Priority review
Orphan drug act
Expedited programs

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Rare Disease Drug Development Course

All ACMA certifications are accredited by IACET/ANSI

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Module Breakdown

Rare Diseases Drug Development

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.

Customer Reviews

4.6 | (500 + Graduates)

Value For Money

4.6/5

Easy to Navigate

4.7/5

Program Content

4.7/5

Reviews Mention

Perfect resource
competitive edge
attracted recruiters
packed with information
  • Neil Gillette, PharmD, BCMAS
    Neil Gillette, PharmD, BCMAS

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.

  • Annie Bouchard
    Annie Bouchard

The program was very informative and provided an excellent perspective. In addition, it complemented and confirmed my acquired knowledge in the Medical Affairs environment.

  • Gianluca Stivale, BCMAS
    Gianluca Stivale, BCMAS

It is an enriching Medical Affairs program with extremely positive impact on daily job

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