Courses
Pharma Courses offered by MediArck Pharma Training Solutions
CLINICAL TRIAL MANAGEMENT
Clinical research plays a vital role in determining the safety and effectiveness of medications and treatment regimens intended for humans. Clinical trials are usually undertaken for prevention, treatment, analysis or for relieving symptoms of a disease.
Clinical Trial Management (CTM) training allows one to acquire skills and techniques, necessary to collaborate efficiently with other healthcare professionals in basic sciences and other disciplines which results in conduct of high-quality clinical trials.
This course throws light on the introduction and evolution of clinical trials, provides an overview of the designs and types of clinical trials- phase 0 to phase IV, in-depth knowledge of guidelines and regulations for clinical trials- NDCT rule, ICH GCP, functioning of ethics committees as per regulations, etc., skills required for the execution and management of clinical trials- development of protocol, ICF and patient diary, subject enrollment, documentation and filling in the clinical study, understanding of CRF guidelines and entries, managing site visits, pre and post site activities, trial close-out.
Job opportunities:
- Research intern
- Clinical research associate (CRA)
- Clinical research coordinator (CRC)
- Clinical trial project coordinator
- Research interviewer
- Clinical trial assistant
CLINICAL DATA MANAGEMENT
Clinical Data Management (CDM) is responsible for the horizonal process of clinical data from collection to delivery for statistical analysis in compliance with regulatory requirements. CDM mainly centers on dataflows and data integrity so that the data is managed in the best way to maintain its credibility and reliability.
This course introduces certain important concepts and practical approaches to assist planning, collection, storage and dissemination of clinical trial data. Acquiring and applying effective data management principles is the core of CDM.
Training will be focused on building up the skill sets in handling trial data through practical lessons (data management software tools), short quizzes, and hands-on exercises which boosts the confidence of the candidate to have a successful career.
Job opportunities:
- Clinical Data Coordinator
- Clinical Data Associate
- Clinical Data Analyst
- Clinical Data Reviewer
PHARMA COVIGILANCE
Pharmacovigilance encompasses the safety and risk aspects which must be addressed in order to ensure patients receive safe therapy.
This course will provide the students practical knowledge about drug safety monitoring, risk management, good pharmacovigilance practice (GVP), and equips them with skills necessary to predict and analyze drug interactions.
Training will be focused to provide an insight into critical aspects such as adverse event reporting (clinical and post-marketing), periodic safety update reports, reference safety information documentation, signal detection, narrative writing, risk management processes and certain specialized areas of pharmacovigilance such as – vaccinovigilance, hemovigilance, cosmetovigilance and medical devices vigilance.
Job opportunities:
- Drug safety associate
- Safety surveillance associate
- PV Associate
- Drug safety Officer/Manager
- Drug safety analyst/scientist
- Drug safety physician
- Drug safety reviewer
REGULATORY AFFAIRS
The regulatory affairs department of a pharmaceutical company is involved in obtaining approval from the concerned regulatory authorities to develop, launch or market a new medicinal/drug product and to maintain it on the market. It is foremost required that the RA team is well updated with current legislation, guidelines and other regulatory intelligence.
The major objective of this course is to provide knowledge about basic aspects of regulatory affairs, introduction to national and international regulatory bodies, pharmaceutical acts and laws, common technical documents (CTDs) and international marketing authorization procedures. This prepares the candidates to pursue their career in pharmaceutical industry, contract research organization (CROs), drug licensing and control authorities, and export-import agencies dealing with the pharmaceuticals.
Job opportunities:
- Regulatory Affairs Assistant
- Regulatory Affairs Associate
- Regulatory Affairs Executive
MEDICAL WRITING
Well written documents or contents are necessary to present the analysis and interpretation of data in the form of information which suits the target audience – regulatory bodies, clinical research professionals or general public.
Since medical writing requires a clear understanding of medical concepts, terminologies and various sources of authentic scientific information along with good writing skills, this course is designed to provide knowledge about – applied and technical aspects of writing, preparation of clinical and regulatory documents along with preparation of documents for publication in various high impact factor journals.
Job Opportunities:
- Medical Writing Intern/Trainee
- Medical Writer I & II.
- Principal Medical Writer
- Associate Medical Writer
CLINICAL SAS
Clinical SAS is a vital component in the drug development process as the end-to-end data needs to be validated, analysed and interpreted to covert it into an understandable information which is followed by biostatistical analysis.
Apart from applying the biostatistical methods, statistical programming also makes clinical trial reporting possible in the form of ready analysis datasets and production of Tables, Listings and Figures (TLFs). All these activities provide a simple and clear understanding of the safety and efficacy of the investigational product.
This course will train the candidate to become a skilled and successful statistical programmer in certain widely used statistical programming languages such as – Statistical Analysis Software (SAS), Python, R, and MS Excel.
Job Opportunities:
- SAS/R/Python Programmer Analyst
- Statistical Programmer
- Principal Statistical Programmer
- SAS/R/Python -Base Developer
- Data Science Executive
Eligibility
- MBBS/ BDS/ BAMS/ BHMS and Veterinary Science
- Pharmacy Students/Candidates- Pharm/ M.Pharm/ Pharm.D
- BSc. / BSc Life Sciences – Graduate and Post-graduate in: Biological sciences (microbiology, biotechnology, botany, and zoology), basic science (chemistry).
- Nursing, Physiotherapy, Occupational therapy and social sciences.
- Professionals from 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.
- Students from the above courses who are in their final year of graduation.
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