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Regulatory Affairs 101


This brand new comprehensive AAPS online training course was developed for those interested in learning more about the field of regulatory affairs from the perspective of a pharmaceutical scientist. This course will discuss the expansion of marketing pharmaceutical products in emerging markets such as Brazil, Russia, India, and China and how global regulations impact the current drug development process. This AAPS eCourse features:
  • The mission and structure of the US FDA and how to stay informed in a field that is constantly evolving,
  • Essential knowledge required to navigate through the complex regulatory environment,
  • Objectives of various areas such as clinical development and submission,
  • The development process and the regulations that govern development, manufacturing and distribution,
  • Global regulations impact on the drug development process.

Course Objectives

Upon completion of this eCourse, the participant should be able to:
  1. Describe the evolution of drug regulation in the United States;
  2. Explain the various guidances, documents and meetings that are part of the drug development pathway;
  3. Describe the regulatory expectations and various components for an investigational new drug application (IND);
  4. Describe how to build the quality module of a new drug application (NDA);
  5. Discuss the post-approval requirements and where specific details of these requirements can be found (e.g. approval letter, cGMPs, FDA guidances & website);
  6. Describe various Canadian and European regulations regarding drug applications and pharmacovigilance;
  7. Discuss quality by design and statistical procedures as they relate to quality target product profiles, critical quality attributes and risk assessments;
  8. Describe the meaning, importance and key components of Regulatory Intelligence (RI);
  9. List some of the global regulatory challenges and their impact on future drug development; and
  10. Describe pharmaceutical company compliance with the various regulatory requirements associated with different countries, regulatory agencies and Pharmacopeias.
AAPS members, students, and academicians enjoy special pricing. Previews of each of the lectures are available. Participants have access to the course content for a 6 month period following purchase.

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