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Introduction to Non-Interventional Studies (NIS)

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Introduction to Non-Interventional Studies (NIS)

Duration :

1

1 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course :

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

Non-Intervention Studies (NIS) are carried out in uncontrolled settings unlike 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: Introduction to Non-Interventional Studies (NIS)

Lesson 2: Regulatory Framework, Ethical Considerations, and Global Perspective

Lesson 3: Data Protection Regulations and Compliance

Lesson 4: Pharmacovigilance in NIS – PAS, PASS, and PAES

Lesson 5: Study Design and Methodology

Lesson 6: Operational Framework for NIS

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.

Reviews:

 5/5

44

The team now has a good understanding of the ethical and procedural intricacies of NIS. They fared excellently in the quiz, showing that indeed, knowledge has been acquired..

$95

Participant(s):

Buy now

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This course includes:

One-year access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
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HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
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