Advanced Postgraduate Diploma in Clinical Research & Medical Writing
Course
Online
*Indicative price
Original amount in EUR:
890 €
Description
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Type
Course
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Methodology
Online
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Duration
24 Months
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Start date
Different dates available
Medical writing is a rapidly evolving and interesting discipline that comprises of writing subject areas useful for the medical, scientific and healthcare fraternity at large. It also includes writing of documents related to and drug development / clinical research. Two main areas in the pharmaceutical and biotech field where huge demand exists for skilled medical writers are pharmaceutical regulatory writing and medico-marketing writing.
The drug development industry has rapidly progressed in all areas from basic research to bedside research with the scientific and medical writers playing a major role in all phases of product development. Contribution of medical writers is significant in the success or failure of new drugs, therapies and devices.
As per the Center Watch market research analysis conducted in 2008, the medical writing industry has grown at the rate of 15% each year for the last five years to a staggering US $700 million. This rapid growth has been linked to the volume of work outsourced by pharmaceutical and biotech companies in order to meet the applicable regulatory requirements, and to transform clinical trial data into readable documents for scientific and medical publications.
Medical & scientific writers are an essential part of the complete drug & device development process and are responsible for a wide range of activities. Trained medical writers easily find employment in the pharma-biotech and clinical research sector, healthcare companies, press and other print media. They can also provide service as freelance writers.
Facilities
Location
Start date
Start date
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The average rating is higher than 3.7
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Subjects
- Writing
- Industry
- Marketing
- Healthcare
- Medical
- Clinical Research
- Clinical Trial
- Drug Development
- Medical training
- STUDY START-UP
- CLINICAL STUDY REPORT
- Publication WRITING
Course programme
MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY & EVIDENCE BASED MEDICINE
MODULE 03: PHARMACEUTICAL MEDICINE
MODULE 04: THERAPEUTIC AREAS
MODULE 05: ETHICS IN CLINICAL RESEARCH
MODULE 06: ROLES AND RESPONSIBILITIES
MODULE 07: CLINICAL TRIAL PREPARATION
MODULE 08: ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 09: STUDY START-UP
MODULE 10: CLINICAL TRIALS MONITORING
MODULE 11: COMPLIANCE AND AUDITS
MODULE 12: DATA MANAGEMENT AND BIOSTATISTICS
MODULE 13: REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 14: MEDICAL DEVICE TRIALS
MODULE 15: PROJECT AND VENDOR MANAGEMENT
MODULE 16: FINANCIAL MANAGEMENT OF CLINICAL TRIALS
MODULE 17: PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS
MODULE 18: BASICS OF GOOD MEDICAL WRITING
MODULE 19: COMPUTER SKILLS
MODULE 20: OVERVIEW OF THE REGULATORY, MARKETING AND DRUG PROMOTION PROCESSES
MODULE 21: COMMON TECHNICAL DOCUMENT
MODULE 22: PROTOCOL, INVESTIGATOR’s BROCHURE & CASE REPORT FORMS
MODULE 23: CLINICAL STUDY REPORT
MODULE 24: SENTENCE CONTROL
MODULE 25: WRITING FLOW AND COHESIVENESS
MODULE 26: PUBLICATION WRITING
MODULE 27: DOCUMENTS IN MEDICO-MARKETING
MODULE 28: MANAGING THE REVIEW PROCESS
Advanced Postgraduate Diploma in Clinical Research & Medical Writing
*Indicative price
Original amount in EUR:
890 €