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Advanced program in clinical research management,

  • The initiative is targeted at applicants who are interested in joining the clinical research field, in the area of clinical trials, clinical data processing, pharmacovigilance or medical publishing.

Methodik:

The course is delivered by seminars, meetings, group projects, case studies, conferences and site tours performed by leading experts in the industry.

Faculty

PHARMA RESEARCH’s team comprises experienced practitioners with 5-10 years of experience in the Clinical Research sector, who currently work in senior positions with international pharmaceuticals or contract research organizations

Attendance

The nature of the course requires full attendance throughout all sessions. Eighty-five per cent of the attendance is required and five per cent should rest on medical grounds. We can be helped by backup sessions in case students skip several lessons.

Eligibility

  • MBBS/ BDS/ BAMS/ BHMS etc-Candidates with graduate/ post-graduate qualifications in: Medical and allied fields like dentistry, homeopathy, Ayurveda and veterinary science, and pharmacy.
  • Pharma Candidates B.Pharm/ M.Pharm/ Pharm.D
  • M.Sc./ B.Sc (Life Sciences)- Graduate and Post-graduate in: Biological sciences (microbiology, biotechnology, botany, zoology), basic science (chemistry), nursing, physiotherapy, occupational therapy, social sciences with work experience in clinical research.
  • Engineering Graduates (B.E, B.Tech, M.Tech in Biotech)
  • Experience of working in the health/ pharmaceutical sector.
  • Candidates currently engaged in clinical research and related operations such as: Members of institutional ethics committees, faculty members and scientists in medical colleges/ institutions and officials engaged in Clinical Research.

Admissions

The admissions department practices a well-defined and thorough method of acceptance. This method will judge applicants according to a variety of criteria.

Over the years, PHARMA RESEARCH has found that students doing well in the academic program are generally those with consistently good academic records during their elementary, high school and graduation rates, in addition to having adequate telephone or face therapy performance. PHARMA RESEARCH thus uses multiple metrics, including academic performance in kindergarten, high school and graduate programs as well as strong oral and written correspondence.

Examination

At the conclusion of each session, the students will take the monthly exams and seminars. On completion of the final exam successful. Our faculty must evaluate the student’s technological and vertical capabilities, and provide guidance to the course instructor, followed by qualification for training attendance.

Quick Enquiry

 

SHEDULE

CLINICAL TRIAL OPERATIONS

A Clinical Study is a systematic study of new drugs in human subjects to produce evidence for the detection or testing of clinical, pharmacological (including pharmacodynamic and pharmacokinetic) or adverse effects with the goal of evaluating the safety and efficacy of the new drug. In recent years, clinical research industry has grown at an exponential pace around the globe. It has opened up new job prospects for a great number of people.

The worldwide market for clinical trials is worth more than US$ 45 billion and the industry has employed an estimated 2.10,000 people in the United States and over 70,000 people in the United Kingdom, making up one third of the total Research and Development personnel. The fact that this sector offers attractive employment opportunities can be attributed to those large numbers. The total cumulative annual salary increase across all occupations for other divisions is 4 percent as compared to less than 1 per cent.

The course would explain the basic principles of conducting clinical trials, and how to evaluate them.  Terminology used in clinical trials and the various common designs used for clinical trials will be introduced to the participants.  We’ll also explain some of the mechanics of clinical trials, such as randomizing and treatment blinding.  We’ll explain how clinical trials are analysed and understood in the second half of the course.  Finally, we should study the basic ethical consideration that is inherent with performing human experiments.

CLINICAL DATA MANAGEMENT:
Details
Timing: 2 hrs Daily

A Clinical Research is a systematic study of new drugs in human subjects to generate data for discovery or verification of clinical, pharmacological (including pharmacodynamic and pharmacokinetic) or adverse effects with a view to determining the safety and efficacy of the new drug. The Clinical Research Industry has grown at an unprecedented rate around the world over the last few years. It has opened up new opportunities of jobs for a large number of people. The Clinical Trials market is worth more than US$ 45 billion globally and the company has employed an estimated 2.10,000 people in the US and more than 70,000 people in the UK, making up one-third of the total research and development workforce. These large numbers can be attributed to the fact that this sector offers lucrative employment opportunities. The overall cumulative annual salary rise for all jobs is 4 per cent compared to less than 1 per cent for other categories.

PHARMACOVIGILANCE
Pharmacovigilance is a pharmacological science concerned with the detection, assessment, understanding and prevention of adverse reactions, in particular long-term and short-term side effects of medicinal products. In general, pharmacovigilance is a science of collecting, monitoring, researching, evaluating and evaluating information from healthcare providers and patients on the adverse effects of medicinal products.   Pharmacovigilance is particularly concerned with adverse drug reactions or ADRs that are officially defined as: “Response to a medication that is noxious and unintentional and that occurs at doses that are usually used for prophylaxis, diagnosis or treatment of disease, or for physiological function adjustment.”

Medical writing is an exercise in the creation of medical documents by a professional researcher. Typically, the medical writer is not one of the scientists or doctors who did the research. A medical writer, working with physicians, scientists and other subject matter experts, produces papers that effectively and accurately describe research results, product use and other medical information.

The medical writer also ensures that the documents comply with regulatory, journal or other standards in terms of content, format and structure. Medical writing as a tool has become known in the pharmaceutical world because the industry has understood that it requires special skills to create well-structured documents that present information clearly and concisely. Increasing numbers of new drugs are undergoing an increasingly complex process of clinical trials and regulatory procedures leading to market approval. This drives the demand for well-written, standard-compliant documents that science professionals can easily and quickly read and understand.