Non-Interventional Studies (NIS) Module 1: General Principles

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Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course : 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

The backbone of Non-Intervention Studies  (NIS) is that they are carried out outside the controlled setting common to clinical trials. Patients are enlisted based on specific criteria which include their current treatment plan. These studies do not interfere with the current plan, hence, the researchers can identify specific events that influence therapy in the real world. This course serves as an introduction to the fundamentals of NIS. You will learn about the ethics and steps involved in obtaining data and drawing useful inferences from NIS.

 

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

 

 

Curriculum

 

Lesson 1: What is NIS and Some Important Definitions?

 

  • NIS Definitions

 

Lesson 2: Ethical Considerations

 

Lesson 3: Post-Authorization Studies in Europe

 

  • Post-Authorization Safety Study (PASS)
  • Post-Authorization Efficacy Study (PAES)
  • Requirements for Disclosure of Non-Interventional Studies Reports

 

Lesson 4: Post-Authorization Studies in the USA

 

Lesson 5: Operations of the EU Network

 

  • Procedure for Imposing Post-Authorization Safety Studies
  • Request for Post-Authorization Safety Study as Part of the Initial Marketing Authorization Application
  • Request for A Post-Authorization Safety Study During a Post-Authorization Regulatory Procedure
  • Request for a Post-Authorization Safety Study Due to an Emerging Safety Concern
  • Joint Post-Authorization Safety Studies
  • Written Observations in Response to the Imposition of an Obligation
  • Supervision of Non-Interventional Post-Authorization Safety Studies Conducted Under an Obligation
  • Roles and Responsibilities of the Marketing Authorization Holder

 

Lesson 6: Roles and Responsibilities of the PRAC and the National Competent Authority

 

  • Roles and Responsibilities of the Agency

 

Lesson 7: Changes to the Marketing Authorization Following Results from a Non-Interventional Post-Authorization Safety Study

 

Lesson 8: Good Pharmacovigilance Practice

 

  • Objectives of Pharmacovigilance
  • Pharmacovigilance in the EU: Roles of Different Factors
  • Legal Basis, Scope, and Process for GVP
  • Maintenance and Further Development of GVP
  • Structure of GVP

 

Lesson 9: EU Data Protection Regulation – Impact on Clinical Trials & Pharmacovigilance

 

  • What Data Protection Issues Should Be Considered When Conducting Clinical Studies?
  • What Data Protection Issues Should Be Considered When Conducting Pharmacovigilance Activities?

 

Glossary

 

Quiz

Author:

Amita Joshi
Amita Joshi holds a Doctorate in Pharmaceutical Sciences. She has more than 20 years of experience in pharmaceutical dosage form research in Industry as well as academia. She has been a recipient of prestigious GYTI award by DBT, Govt. of India & SRISTI, India for pharmaceutical technology development for the management of HIV. She has published more than 25 peer-reviewed research publications. Amita Joshi is the founder of Biobay solutions. She is currently engaged in providing pharmaceutical technology solutions and scientific communication.

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