Organized by Pharmanext Magazine

International Conference Inetnational Conference on Pharmacovigilance and clinical Research - Regulatory and Ethical concerns around the globe

ABOUT CONFERENCE:

This two-day CLINICAL RESEARCH program for Pharma and Medical professionals will introduce, explain and discuss fundamental concepts and current issues relating to compliance, human subject protection, research development, and clinical investigation in the current regulatory environment. Speakers from academia and industry will share their knowledge and expertise.

The conference will be organized by PHARMANEXT in association with other professional organizations in pharmaceutical, medical and healthcare world.

CONFERENCE OVERVIEW:

The main goal of the conference is to provide advancement in knowledge and skills of persons working or intending to work in clinical research. This conference will be of special use to professionals and students associated with pharmaceutical & biotechnology industry, academic institutions, regulatory agencies, clinical research organizations and healthcare Industry.

The following sets of personnel are encouraged to apply:

  • CRAs & Study Coordinators working in the field who are looking for additional training.
  • Professionals wanting to change career within the industry/academia to clinical research.
  • Professionals willing to get in the field of clinical research.
  • Recently employed personnel in academia or industry requiring comprehensive training in clinical research

The participants will gain knowledge in the following areas:

  • Principles and practices in medical research.
  • Clinical research study designs
  • Laws and regulations governing clinical trials
  • Protocols and ethical standards governing clinical trials.
  • IRB and testing on human subjects
  • Application of statistical concepts to study design
  • Statistical concepts for evaluation of results
  • Accuracy in procedure in reporting outcome
  • Planning and managing a study site
  • Planning and managing a clinical project

The topics proposed for discussion in the conference are:

  • Drug development process
  • Good clinical trials
  • Laws/ regulations governing clinical trials
  • Clinical trials scenario in India
  • Clinical registry in India
  • Ethics Committees / IRBs
  • Clinical trials in pediatric populations
  • Adverse events & ADR reporting
  • Statistical concepts in clinical trials
  • Basics of clinical data management
  • Role of investigators in clinical trials
  • Management of a clinical site
  • Management of clinical trials program