• 1 H.E.J. Research Institute of Chemistry
    International Center for Chemical and Biological Sciences
  • 1 Dr. Panjwani Center for Molecular Medicine and Drug Research
    International Center for Chemical and Biological Sciences
  • 1 Prof. Dr. Atta-ur-Rahman Laboratories (TWC)
    International Center for Chemical and Biological Sciences
  • 1 LEJ National Science Information Center
    International Center for Chemical and Biological Sciences
  • 1 ICCBS Group Photograph
    International Center for Chemical and Biological Sciences
  • 1 LEJ Nanotechnology Center
    International Center for Chemical and Biological Sciences
  • 1 Prof. Dr. Salimuzzaman Siddiqui Auditorium
    International Center for Chemical and Biological Sciences
  • 1 HEJ Library
    International Center for Chemical and Biological Sciences
News

1st Workshop on the Common Technical Document - May 20th, 2017








The Common Technical Document (CTD) is a set of specification for application dossier for the registration of medicines and designed to be used across Europe, Japan and the United States. It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (FDA, US) and the Ministry of Health, Labour and Welfare (Japan). The CTD is maintained by the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

AREAS OF FOCUS:

a) Rationale for CTD.
b) Understanding of prevailing regulations & guidance
c) Quality Overall Summary (module 2)
d) Chemistry manufacturing and controls (Quality) (Module 3)
e) Non-clinical/Preclinical (Safety) (Module 4)
f) Clinical (Efficacy) (Module 5)


SPEAKERS:

• Sultan Ghani
• Dr.Iftikhar Jafri
• Dr. Obaid Ali Et al.,

DOWNLOAD REGISTRATION FORM

DOWNLOAD POSTER


VENUE:

Center for Bioequivalence Studies and Clinical Research(CBSCR)
HEJ Research Institute of Chemistry.
International Center for Chemical and
Biological Sciences, University of Karachi-(ICCBS)
TIMING: 9:00AM – 5:00PM

REGISTRATION FEES:

PKR 1000 only for Students.
PKR 3000 only for Professionals.


Online Registration:

Send scan copy of Filled Registration form and Pay order/ Bank Deposit slip (Account # 1146-0101-8338, UBL, University of Karachi Branch, Account Title: -DIRECTOR CBSBR- at the Official CBSCR Email I.D.

If, Registration Fee in cash: Submit your cash along with filled registration form at reception of HEJ Research Institute of Chemistry, ICCBS, University of Karachi.

NOTE: Bring your Original N.I.C and Registration form and Bank Deposit Slip/ Pay order on the day of Session. Registration Forms are also available on face book Page.

E-mail: cbscr.hr@gmail.com
Cell #: +923351272780
+923002209705
Face book Page/ Group:
Center for Bioequivalence Studies and Clinical Research

International Center of Chemical and Biological Sciences, University Of Karachi
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