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  1. Courses
  2. Regulatory Affairs 101

Regulatory Affairs 101

Welcome

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.


Purchase Now
Purchase the entire course—all 10 lectures—at an even greater discount by clicking the button below. Interested in just a lecture or two? Scroll down to add lectures to your cart individually. 

 ($359.00-$799.00)

$51.00 - $119.00
Student
$51.00
E-Subscriber
$119.00
Member
$99.00
Non-Member
$119.00

1: Introduction to Regulatory Sciences: An Overview

Presentation: CAPT. Dennis Bashaw, Pharm.D., 58 min 32 sec

Assessment- Lecture 1

Assessment: 7 questions 5 retakes

Evaluation - Lecture 1

Survey: 13 questions

Introduction to Regulatory Sciences: An Overview

Certificate: 0/3 Course items completed
$51.00 - $119.00
Student
$51.00
E-Subscriber
$119.00
Member
$99.00
Non-Member
$119.00

2: Regulatory Processes Leading to IND

Presentation: Jogarao Gobburu, MBA, Ph.D., 30 min 47 sec

Assessment- Lecture 2

Assessment: 6 questions 5 retakes

Evaluation - Lecture 2

Survey: 13 questions

Regulatory Processes Leading to IND

Certificate: 0/3 Course items completed
$51.00 - $119.00
Student
$51.00
E-Subscriber
$119.00
Member
$99.00
Non-Member
$119.00

3: Regulatory Processes Leading to NDA Submission

Presentation: Ramani Raghavan, Ph.D. , 67 min 22 sec

Assessment- Lecture 3

Assessment: 7 questions 5 retakes

Evaluation - Lecture 3

Survey: 13 questions

Regulatory Processes Leading to NDA Submission

Certificate: 0/3 Course items completed
$51.00 - $119.00
Student
$51.00
E-Subscriber
$119.00
Member
$99.00
Non-Member
$119.00

4: Commercialization and Post Submission Support

Presentation: Frank Diana, Ph.D., 63 min 9 sec

Assessment- Lecture 4

Assessment: 10 questions 5 retakes

Evaluation - Lecture 4

Survey: 13 questions

Commercialization and Post Submission Support

Certificate: 0/3 Course items completed
$51.00 - $119.00
Student
$51.00
E-Subscriber
$119.00
Member
$99.00
Non-Member
$119.00

5: A Close Look at Chemistry Manufacturing and Controls (CMC) Sections

Presentation: Lynn Gold, Ph.D., Edward Narke, Ph.D., 71 min 21 sec

Assessment- Lecture 5

Assessment: 7 questions 5 retakes

Evaluation - Lecture 5

Survey: 13 questions

A Close Look at Chemistry Manufacturing and Controls (CMC) Sections

Certificate: 0/3 Course items completed
$51.00 - $119.00
Student
$51.00
E-Subscriber
$119.00
Member
$99.00
Non-Member
$119.00

6: Regulatory Responsibilities to Ensure Product Quality: Quality Systems, Quality by Design (QbD)

Presentation: Kristi Griffiths, Ph.D. , Sharmista Chatterjee, Ph.D., 51 min 30 sec

Assessment- Lecture 6

Assessment: 14 questions 5 retakes

Evaluation - Lecture 6

Survey: 13 questions

Regulatory Responsibilities to Ensure Product Quality: Quality Systems, Quality by Design (QbD)

Certificate: 0/3 Course items completed
$51.00 - $119.00
Student
$51.00
E-Subscriber
$119.00
Member
$99.00
Non-Member
$119.00

7: Europe (EMA) and Canada (Health Canada)

Presentation: Umang Shah, Ph.D. , 71 min 41 sec

Assessment- Lecture 7

Assessment: 11 questions 5 retakes

Evaluation - Lecture 7

Survey: 13 questions

Europe (EMA) and Canada (Health Canada)

Certificate: 0/3 Course items completed
$51.00 - $119.00
Student
$51.00
E-Subscriber
$119.00
Member
$99.00
Non-Member
$119.00

8: Global Regulatory Affairs: Regulatory Processes in the Emerging Markets

Presentation: Ganapathy Mohan, Ph.D. , 51 min 12 sec

Assessment- Lecture 8

Assessment: 8 questions 5 retakes

Evaluation - Lecture 8

Survey: 13 questions

Global Regulatory Affairs: Regulatory Processes in the Emerging Markets

Certificate: 0/3 Course items completed
$51.00 - $119.00
Non-Member
$119.00
Student
$51.00
E-Subscriber
$119.00
Member
$99.00

9: Regulatory Intelligence and Staying Informed

Presentation: Marjo Gazak, Ph.D., Shanthi Sethuraman, Ph.D., 38 min 4 sec

Assessment- Lecture 9

Assessment: 8 questions 5 retakes

Evaluation - Lecture 9

Survey: 13 questions

Regulatory Intelligence and Staying Informed

Certificate: 0/3 Course items completed
$51.00 - $119.00
Student
$51.00
Member
$119.00
E-Subscriber
$99.00
Non-Member
$119.00

10: Regulatory Compliance/Requirements and Guidance

Presentation: Prabu Nambiar, Ph.D., MBA, RAC, Kim Huynh-Ba, MS, PMP , 102 min 7 sec

Assessment- Lecture 10

Assessment: 8 questions 5 retakes

Evaluation - Lecture 10

Survey: 13 questions

Regulatory Compliance/Requirements and Guidance

Certificate: 0/3 Course items completed
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