Certificate Course in Clinical Research (CCCR)

Description

If you find the Clinical Research field challenging, well, in that case, this is the best course for you.

The pharmaceutical industry is one of the extremely regulated industries, with several government regulations to protect public health. Therefore, the important target of the pharmaceutical industry is to develop a Drug product passing the regulatory requirements. On the other hand, regulation of drug development, manufacturing, marketing, and sales involves paradoxical objectives. It must ensure that safe and effective pharmaceutical formulations reach the public quickly while concurrently protecting against ineffective/unsafe/harmful therapies. This course will provide you with a strong understanding of the Drug development process, Clinical Research and related documents, GCP, Roles, and responsibilities of major players in Clinical Research in a summarized manner which will help to work towards shaping your career in Clinical Research.

This course focuses on the following points that could make Clinical Research activities smooth without any significant delays/failures,

• Basic Understanding of Clinical Research,

• Major players in Clinical Research,

• Historical background of US Drug Law and Regulations,

• Drug Approval Process,

• New Drug Development-Preclinical Steps

• Investigational New Drug Application (INDA),

• New Drug Application (NDA),

• Abbreviated New Drug Application (ANDA),

• Essential Documents,

• Protocol,

• Source Documents,

• Informed Consent form,

• Investigator’s Brochure,

• Case Report Form (CRF),

• Inclusion-Exclusion criteria,

• Sponsor,

• Investigator,

• Clinical Research Associate (CRA) and Clinical Research Coordinator (CRC),

• Important Literature Search Websites for Clinical Research Professional,

• Many more...

There will be several downloadable documents so that you can follow along with them whenever you need them.

This course contains Commonly Asked Questions that will help you while preparing for Clinical Research interviews.

Last but not the least, this course also contains a bonus course entitled "Meeting etiquettes" which will help you to shape your career in which the points that must be taken into consideration while attending/conducting meetings are covered.

In this course, more than 30 informative videos are included and are designed in an easily digestible format and going to take you through step by step approach to understand Clinical Research and relevant activities.

I believe "Quality improvement is a continuous and lifetime process". Upon completion of this course, you will be a whole different professional with improved Clinical Research knowledge which will help you to garner more respect from your team members, managers, clients, or anyone with whom you are communicating/interacting.

What You Will Learn!

• Basic understanding of Clinical Research
• Historical background of US Drug Law and Regulations
• Drug approval process in USA, New drug development-Preclinical Steps, IND, NDA, ANDA
• Essential Documents in Clinical Research
• Protocol
• Source Documents
• Informed Consent Form (IC Form)
• Investigator's Brochure (IB)
• Patient Information Sheet
• Case Report Form (CRF)
• Inclusion-Exclusion Criteria
• Information related to Sponsor, Investigator, Clinical Research Coordinator (CRC), Clinical Research Associate (CRA)
• Discover how to navigate important websites including ICH Guidelines to find more relevant information.
• Professional reputation building and career success enhancement through proper understanding of Clinical Research and related concepts and many more...

Who Should Attend!

• This course is for Clinical Research Professionals, Pharma entrepreneurs, Pharma Consultants, Pharma Industry Professionals dealing with Clinical Research and related activities.
• Pharma Faculties, Graduates, Postgraduates, PhD. Students (Pharmacy, PharmD, Science, Medical).
• Anyone who is eligible and wants to make a career in Clinical Research.

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