Introduction to Harmonization Activities

The process of establishing uniform standards for the pharmaceutical industry is known as harmonization. Comparing clinical trial data is challenging since different countries conduct clinical studies using different protocols. This module's advanced principles help you comprehend why it's important to standardize the clinical data management process internationally. Eliminating needless delays in the global development and accessibility of new medications is the primary goal of this approach. Standard operating procedures in clinical trials and laid protocol helps in this direction.

Course Description

Harmonization is the process of creating common standards across the pharmaceutical market. Clinical trials carried out in different countries follow varied procedures which makes it difficult to compare the clinical trial data. The Advanced Concepts in CR LVL 1 module gives you an understanding into the need to harmonize the clinical research process across countries. The main objective of this process is to eliminate unnecessary delay in the global development and availability of new medicines.

Who should apply?

  • MBBS/BHMS/BAMS/BPT/MPT/BDS/BMLT/Bachelor in Naturopathy & Veterinary Science /MD/MS.
  • Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
  • Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
  • Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
  • Graduate or equivalent degree in Nursing/Allied Health.
  • Students in their final year of graduation for the above courses may also apply.

What you will learn in this course

This program will help the life science and health science graduates to learn about the need to harmonize clinical research processes and factors contributing to delays in global development and availability of new medicines.

Structure of Course Delivery

The entire course leading to clinical research certification in this context of harmonization activities will be made available online. It consists of several in-depth lectures delivered by a subject matter expert, appropriately supported by slides, images, and interactive materials where necessary. The delivery has a tremendous degree of versatility. A class may be paused to allow you to take notes and refer to your textbooks (not provided). If you already know a certain part of the lecture, you can rewind it to hear it again or skip a slide or two. You are free to go back over a section at a later time if you need to review it before your assessment. You are free to take the topics in this course in whatever order you choose, even though our curriculum may prescribe otherwise.

Benefits

Many of our students felt that the way this course is taught has made it easier for them to keep up with the intense lectures in real class— it's like having a TV remote in class to self-pace your teacher.

Visuals in the presentations aid in better comprehension by making topics easier to learn... and more difficult to forget!

Chapters

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Dr Divya Sunil
Academic Mentor

Dr. Divya Sunil has graduated with a degree in Dentistry from Bangalore University and a PG Diploma in Clinical Research. She is passionately involved in training and motivating students who are new to the world of clinical research.

Dr. Divya is proficient in Pre-Clinical Studies, laws governing the production of drugs, designing the database for Clinical studies, medical coding, and guidelines for post-marketing surveillance.

Previously, Dr. Divya has worked as an academic mentor at a private dental college in Bangalore where she has taught more than 10,000 students. She has also co-authored an article in the monthly journal,” TRENDS IN PROSTHODONTICS” VOL 4, NO. 1 (2013) on Bone Implant contact and its relationship with the strain on the surrounding bone.

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Dr. Smitha Seshagiri
Academic Mentor

Dr. Smitha Seshagiri has completed her PGDCR from Avigna Clinical Research Institute. She has an experience of 4+ years. She is also a practicing dentist and a wellness coach.

This program will provide the students with an opportunity to work with various MNCs.

Students can get engaged in different profiles like

  • Clinical Trial Analyst
  • Clinical Trial Assistant
  • Clinical Research Coordinator
  • Clinical Research Associate
  • Quality Control
  • Quality Analyst
  • Regulatory Associate
  • Regulatory Specialist
₹6999

₹3999

  • Duration 6 Hours
  • Chapters 6
  • Skill Level Beginner
  • Language English
  • Instructor Dr Divya Sunil
  • Instructor Ms Amrutha Babu
  • Instructor Dr Smitha Seshagiri
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