Advanced Postgraduate Diploma in Clinical Research & Pharmacovigilance

Curso

Online

890 €

Descrição

  • Tipologia

    Curso

  • Metodologia

    Online

  • Início

    Datas a escolher

The drug development industry is changing in a way where innovation and drug safety are not separate from one another. New business models are maturing leading to the development of new generation therapies and to a coexistence of these newer drugs and well known blockbuster treatments from the past.
Pharmacovigilance is now an essential component of the life cycle of almost all healthcare related products. This is because of a demand for safer and more effective drugs and changes in regulations applicable to their research, development and marketing.
Many global companies such as Pfizer, Quintiles, GlaxoSmithkline etc have developed their own pharmacovigilance centres in all major clinical research regions around the world including India. In addition, local drug companies in these regions are also stepping up their work in research and development for both promising new molecules as well as generics. An industry analysis carried out by Frost & Sullivan titled ‘World Pharmacovigilance Markets in Lifesciences’ has found that the while the global pharmacovigilance industry in 2008 was valued at US $1859.9 million it is estimated to touch US $2252.2 million by 2015. This business report also emphasizes the shifting focus of key drug companies towards outsourcing their pharmacovigilance functions to smaller specialized pharmacovigilance service providers. Developing regions such as India, Latin America etc are slowly becoming a hub for pharmacovigilance business.
In November 2004, the Indian ‘Central Drugs Standard Control Organization’ (CDSCO) launched the National Pharmacovigilance Program under the aegis of Directorate General of Health Services and the Union Ministry of Health and Family Welfare which has now been replaced by the Pharmacovigilance Program of India (PvPI) introduced in 2010.

Opiniões

Matérias

  • Global
  • Industry
  • Clinical Research
  • Regulations
  • Pharmacoepidemiology
  • Biostatistics
  • Pharmaceutical Medicine
  • Therapeutic AREAS
  • MEDICAL DEVICE TRIALS
  • STUDY START-UP

Programa

Program Structure

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: PRINCIPLES OF PHARMACOVIGILANCE
MODULE 19: PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
MODULE 20: PHARMACOVIGILANCE SYSTEMS
MODULE 21: GLOBAL PHARMACOVIGILANCE AND SAFETY STANDARDS
MODULE 22: PHARMACOVIGILANCE REGULATIONS AND GUIDELINES
MODULE 23: PHARMACOEPIDEMIOLOGY

Advanced Postgraduate Diploma in Clinical Research & Pharmacovigilance

890 €