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clinical research

Advanced PG Diploma in Pharmacovigilance & Clinical Data Management

FEE: 15999/-

To learn the applicable clinical research guidelines, personnel & stakeholders responsibilities, clinical trial study processes, Clinical Data management, Pharmacovigilance etc.

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Advanced Post Graduate Diploma in  Pharmacovigilance and Clinical Data management

Designed primarily for students of pharmacy, clinical research and allied health professions, Introduction to Statistics in Pharmaceutical Clinical Trials will also be invaluable to professionals entering the pharmaceutical, biotechnology and contract research organization industries who wish to gain a broader understanding of study design, data validation, data entry system tools, data programming and e-learning software.

Pharmacovigilance is critical to ensure the continued safety of drugs, as information on potential harms of a drug is incomplete when the drug is launched. Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. Pharmacovigilance begins at the clinical stage and continues throughout the life cycle of the drug, mainly divided as pharmacovigilance during the clinical phase and post marketing. The process of collection of such information about a drug begins in phase I of the clinical trial, before approval of the drug, and continues even after approval; several post-market safety studies are conducted, with many made mandatory by drug regulatory agencies around the world.

We have divided the course in three modules. In First module, we cover the basic aspects of Clinical Data Management. In the second module, we cover core CDM knowledge like data validation and data development. In the third modules, we cover Pharmacovigilance knowledge like the regulations, signal detection, risk benefit analysis, medical dictionaries,

 

Course Objectives:

• To provide a comprehensive introduction to the Clinical Data Management process and Pharmacovigilance and Global Pharmacovigilance regulations.
• Learn the skills, knowledge and competencies of a candidate for the CDM.
• Practical aspects of important Pharmacovigilance activities as per the global standards like medical evaluation, casualty assessment, expectedness assessment, case narratives, MedDRA, case processing preparation of safety report etc
• Become more familiar with roles/jobs as part of the study team.
• Understanding of Databases , management of clinical data and Pharmacovigilance.
• Understanding of key enterprise clinical data management tools and Pharmacovigilance safety

International authors Clinical research, Phamacovigilance & Clinical Data Management eBooks lifetime accessibility

MODULE -1

  1. Introduction to Clinical Data Management
  2. Clinical Data Management
  3. Medical Coding in Clinical Data
  4. Clinical Data Process
  5. Case Reporting Form
  6. Quality & Regulatory system

 

MODULE -2

  1. Introduction to Pharmacovigilance
  2. Signal Detection and causality assessment
  3. Statistical reasoning and algorithms in pharmacovigilance
  4. Medical dictionary for Drug Regulatory Activities (MedDRA)
  5. Individual Case Safety Report (lcsrs)
  6. Periodic Safety update report (PSUR)
  1. What will be the mode of learning and do I need to visit anywhere to take this course?
    The mode of learning is completely online and you are not required visit anywhere to take this course. You can easily learn and complete this course from your location. You should have a device (laptop/ desktop) with internet connect.
  1. How will you deliver the course modules?
    You simply need to log in with the Username and Password at our Online Moodle Portal to start learning. The access will be granted to you via email within 24 hrs. of fee payment.
  1. I am a student at present; can I take this course along with my studies?
    Yes, you can take this course along with your regular studies.
  1. Is there any specific timing to take the course modules?
    We have made it very convenient for you. All the course modules are pre-loaded on the website, so you can learn the modules as per your convenient timings.
  1. How will you conduct the exams?
    Exams will be online. Once you are through with course modules and want to take examination, you just need to drop a request mail at info@pharma-research.in.
     Request to take the online exam can be sent at any time.
  1. When will I receive the Certificate and Performance Card?
    Once you attempt and submit your online exam for evaluation, we generally take 7 business days to evaluate and issue Certificate of Completion along with Performance Card
  1. How will you send the Certificate of Completion?
    The Certificate would be issued through email upon successful completion. The issued certificate would be print-ready but if you wish to receive a hard copy of Certificate then a minimal charge towards processing, printing and courier would be applicable.
  1. How to enroll and pay the fee?
    To enroll, you simply need to view the link HOW TO ENROLL.
  1. Can I pay the fee in installments?
    Yes, you can pay the fee in maximum 3 installments. To pay the fee in installments, you need to contact us at info@pharma-research.in

You can also view our FAQs page for further queries.

– Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
– Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
– Any degree in Pharmacy / Pharmaceutical Sciences
– Any degree in Chemistry / Biostatistics / Bioinformatics
– Any degree in Nursing / Allied Health.
– Students in their final year of graduation for the above courses are also eligible to apply.

If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in clinical research / pharmacovigilance / allied areas. Please contact our admission representatives / counsellor to discuss your case.

Student 3200

Length: 4 weeks

Timings: Self Paced

Language: English

Effort: 55 hrs. approx

Skill Level: All

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