Want to move forward in your career?

ICH-GCP Certificate ProgramVenue: Center for Executive Education (CEE), IBA City Campus, Karachi.

Date: 14th May, 2017 | Day: Sunday | Time: 9:00am - 1:00pm | Duration: 10 Weeks

Program Overview:

International Conference on Harmonization of Good Clinical Practice (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 develipment. 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 Pharmacueticals, Clinical Research, NGO’s and

academia both Nationally and internationally.

For Further InformationCenter for Executive Education (CEE)Institute of Business Administration (IBA),City Campus. Off Garden Road, Karachi-74400.

Tel: (92-21) 38104701 (Ext. 1808, 1809, 1812)Fax: (92-21) 38103008Email: marehman@iba.edu.pk

cee.iba.edu.pkhm.iba.edu.pk

Contact us for Client Specific Customized Executive Programs & Consultancy

EDUCATIONEXECUTIVEExperience

Center for Executive Education, IBA, Karachi

Center for Executive Education (CEE)Institute of Business Administration City Campus.Off Garden Road, Karachi-74400.

Program FeesPKR 40,000 per Participant

Trainer’s Pro�le:

Who Should Attend?

Mr. Khurram Zaki Khan. Having more than 25 years of clinical research and medico marketing experience Both locally and globally. Managed > 30 phase II, III and IV clinical studies all over pakistan and has coordinated clincal. roteomic and genomic research management in pakistan in collaboration with US and EU

based acadamic Institites.

Those working in pharma industry or intend to join or conducting clinical research or interested in doing so and willing to move forward in thier Career.

Basic of Reseach, Research Classification, Drug Development ProcessICH-GCP GuidelinesStudy Design & Documents ( Study Protocol, IB, ICF)Clinical Site Selection, Site Staff Roles & ResponsibilitiesCRA responsibilities & Activities-I ( Pre, During & Post Study Activities, Computerized System used in clinical trails- IVRS, eCRF)CRA Responsibilities & Activities-II ( Planning, SDV, Discussion With Site Staff, Post Monitoring FU etter, CTM Archiving, Documents CRF & eCRF, Patient Diariesm Financial Disclosure, From 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)Roles of Regulatory bodies in the approval of clinical trails FDA, EU and PakistanPharmacovigilanceBasics of Protocol Writing

•••••

•

•

•••

Course Contents: