Weekend Certificate Program in International Conference on Harmonization of Good Clinical Practices (ICH-GCP) May 14, 2017

Time: 9:00am – 1:00pm Download PDF
Venue: CEE@IBA,Karachi Reg Form
Days: Sundays  
Duration: 10 Weeks  
Info: marehman@iba.edu.pk  
Contact: Tel: (0213) 8104700 (Ext:1808, 1809, 1812)  

Program Details:

International Conference on Harmonization of Good Clinical Practices (ICH-GCP) Certificate Program is a unique course designed to "professionalize the research occupation"; It will develop individual capacity in the field of clinical research and cater to both beginners and on job personnel to keep them at the cutting edge of clinical research development. International ICH-GCP guidelines are described through interactive sessions, workshops and practical assignments by experts of this field. Course content is designed around human subject protection, ethics, data quality and regulatory compliance. The course is geared up to enhance the marketability and job opportunity of the individuals in the Pharmaceuticals, Clinical Research, NGOs' and Academia both nationally and internationally.

Mr. Khurram Zaki Khan is the founder of outsource clinical research business in Pakistan and is the CEO of Dimension Research® CRO&SMO. He is a Microbiologist by Profession, did his Masters from University of Karachi and Post Graduate Diploma in Bacteriology form Victoria University Manchester UK.

He has more than 25 years of Clinical Research and Medico Marketing Experience with Multinational companies and with his own company. He is an international trainer on Clinical Research Techniques and Processes and has trained personnel in UK, Indonesia and initiated the first international certification course in clinical research in Pakistan. He is also trained as an ISO Lead Auditor by Lloyd's UK.

He has managed > 30 Phase II, III and IV clinical studies all over Pakistan in the fields of Oncology, Endocrinology, Neuroscience, Osteoporosis and Infectious Diseases, Transplant as well as PK studies. He has coordinated clinical, proteomic and genomic research management in Pakistan in collaboration with US and EU based academic institutes.

  • Basics of Research, Research Classification, Drug development process.
  • ICH-GCP Guidelines
  • Study design & Documents (Study Protocol, IB, ICF)
  • Clinical Site Selection, Site Staff Roles & Responsibilities.
  • CRA responsibilities & Activities-I (Pre, During & Post study activities, Computerized systems used in clinical trials-IVRS, eCRF)
  • CRA responsibilities & activities-II (Planning, SDV, Discussion with site staff, Post monitoring FU letter, CTM, Archiving, Documents CRF & eCRF, Patient Diaries, Financial disclosure, Form 1572, Site Staff Signature sheet, Source documents agreement, Confidentiality agreement, Site Visit log, Drug accountability log, Drug destruction log, Monitoring visit log, Contact Visit log)
  • Ethics in Clinical Research (ERC formulation, documents reviewed by ERC, ERC authorities & decisions, Ethical Dilemma and Issues).
  • Role of Regulatory Bodies in the approval of Clinical Trials FDA, EU and Pakistan.
  • Pharmacovigilance
  • Basics of Protocol Writing.
  • Those working in pharma industry or intend to join or conducting clinical research or interested in doing so.
  • Apply the knowledge of the International Commission for harmonization & Good Clinical Practice Guidelines (ICH-GCP) in understanding and development of different Phases of clinical research studies
  • Be able to prepare study related Protocol and related documents
  • Understand the regulatory approval process that is applied at different levels of drug development
  • Be able to act as a study monitor / coordinator or Investigator
  • Act as a key team member in the pharmaceutical, academic institutes and NGOs involved in research studies
  • Could established concept of Medico Marketing in their organization
  • Understand the role of research and its benefits in real life/business scenarios
  • Become qualified to be part of international clinical research teams at different levels

PKR 40,000/- per participant.