Introduction to Scientific Community - Roles & Responsibilities

The ethical and regulatory compliance of human trials is contingent upon the efforts of all research participants, each of whom is a key player in the process. The primary players in the research team are described in detail in this module of clinical research & regulatory affairs. By comprehending this subject, you will be able to apply for jobs in marketing, regulatory affairs, and pharmacovigilance in the pharmaceutical research and development business.

Course Description

Each and every person involved in the research plays a critical role to ensure that human trials are conducted ethically and as per the regulatory standards. The Advanced Concepts in Clinical Research Level 2 module elaborates on the roles and responsibilities of the key players of the research team. Understanding this module will open career opportunities in pharmaceutical research and development sector for positions in pharmacovigilance, regulatory affairs and marketing.

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 importance of regulatory standards in clinical trials, understand the roles & responsibilities of the key research team members, and get a comprehensive idea of career opportunities in pharma research, pharmacovigilance, regulatory affairs and marketing.

Structure of Course Delivery

The entire course 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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Ms Amrutha Babu
Academic Mentor

Ms. Amrutha is an accomplished academic expert in the field of Food and Nutrition. She has a Master’s degree from Mahatma Gandhi University, Kottayam where she graduated with a gold medal. After undergoing training in Christian Medical College, Vellore started her career as a freelance diet counselor in 2009. She was also associated with Lybrate - an online platform for diet management and counseling.

After a remarkable experience in the field of dietetics, she received a post-graduate diploma in Clinical Research. Currently, she is associated with TrueLessons as an academic mentor. Her core strengths are providing excellent teaching and guidance to her students. Amrutha has more than 7 years of teaching experience in the field of clinical research. She has in-depth knowledge about Drug Discovery Process, Drug Approval process, Trial documents, Trial Design, Regulatory Affairs, Query writing, ICSR, and so on.

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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
  • Investigators and Sub-investigators
₹5999

₹3999

  • Duration 7 hours
  • Chapters 7
  • Skill Level Beginner
  • Language English
  • Instructor Dr Divya Sunil
  • Instructor Ms Amrutha Babu
  • Instructor Dr Smitha Seshagiri
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