Symposium Flyer final - International Center for Chemical and

INVITATION
2 N D SYMPOSIUM ON
BIOEQUIVALENCE AND
BIOAVAILABILITY
STUDIES
November 18th-19th, 2014
Organized by:
CENTER FOR BIOEQUIVALENCE STUDIES
AND CLINICAL RESEARCH (CBSCR)
OF
DR. PANJWANI CENTER FOR MOLECULAR
MEDICINE AND DRUG RESEARCH
(INTERNATIONAL CENTER FOR
CHEMICAL AND BIOLOGICAL SCIENCES)
UNIVERSITY OF KARACHI,
KARACHI-75270, PAKISTAN
It gives an immense pleasure to invite you to
The
Second
National
Symposium
on
Bioequivalence and Clinical Studies, to be held
at Center for Bioequivalence Studies and
Clinical Research of Dr. Panjwani Center for
Molecular Medicine and Drug Research,
(International Center for Chemical and
Biological Sciences, University of Karachi,
Karachi-75270, Pakistan) on November 18th 19th, 2014 in Karachi. Several eminent experts
in the field will deliver lectures in this event.
Bioequivalence and bioavailability studies are
important for the development of high quality of
new drug products and their generic
equivalents. The extent to which the active
ingredient or active moiety in pharmaceutical
equivalents or pharmaceutical alternatives is
available at the site of drug action, when
administered at the same molar dose under
similar conditions, is extremely important for the
development of new formulations. Provision of
bioavailability and/or bioequivalence study data
is also an important element in Investigational
New Drug Applications.
This 2-days symposium will provide an in-depth
understanding of the theory; practice and critical
issues related to bioequivalence (BE)
assessment of oral dosage forms (immediate
release
and
modified
release).
The
presentations by international experts from
industries, academia and health authorities, will
focus on the current EMA, FDA, ICH-GCP and
WHO guidelines (and revisions), regarding the
study of bioequivalence of oral dosage forms for
the manufacturing of high quality medicine.
Emphasis will be on practical challenges
encountered during the planning/execution of
BA/BE studies, as well difficulties commonly
experienced with the pharmacokinetic and
statistical analysis of the study results.
Kindly nominate most appropriate staff
members of your esteemed institution/
organization by November 10th, 2014 for the
symposium on this important topic. We are
looking forward to welcome your nominee in
Karachi for the event.
AREAS COVERED
a) Designing bioavailability studies
b) Different components of bioavailability
studies will be evaluated.
c) Evaluate results from bioavailability studies
d) Testing of the comparative bioavailability of
a reformulated and original product and
thereby to determine their equivalence.
e) Understanding of prevailing Regulations &
Guidance
f) Rationale for conducting BE studies.
g) Statistical Design and analysis of BE and
BA studies.
h) The design and execution of BE studies in
general.
i) How to establish that a new formulation has
therapeutic equivalence in the rate and extent
of absorption to the reference drug product.
j) Importance of BE and BA studies for postapproval changes in the marketed drug
formulation
k) Awareness about the Data requirements and
study design
INTERNATIONAL ADVISORY COMMITTEE
1) Prof. Dr. Heiko Iven (Germany)
2) Prof. Dr. Daniel Hoessli (Switzerland)
3) Prof. Dr. Amal Al-Aboudi (Jordan)
ACCOMMODATION
On-campus accommodation will be provided on
payment basis (only for outstation participants).
VENUE
Prof. Dr. Salimuzzaman Siddiqui Auditorium,
International Center for Chemical and Biological
Sciences (ICCBS), University of Karachi,
Karachi-75270, Pakistan.
LANGUAGE
The official language of the symposium is
English.
REGISTRATION
Pharmaceutical Professionals, R&D Institutions,
Universities and Students of Biological Sciences
and Pharmacy.
Registration before November 10th, 2014 is
encouraged.
 Pharmaceutical
Industries
and
R&D
Institutions Rs. 5,000/ Faculty Members Rs. 2,500/ University Students Rs. 1,000/Registration payment should be submitted
through pay order in favor of Director
CBSBR, ICCBS, University of Karachi or
through Cash to Financial Coordinator (Mr.
Rizwan Ishaq) at CBSBR, ICCBS, University
of Karachi along with registration form.
Registration form can be download from our
websites www.cbsbr.org, www.iccs.edu
or request to secretaries.
Dr. Naghma Hashmi
Prof. Dr. Atta-ur-Rahman F.R.S., N.I., H.I., S.I., T.I.
Coordinator
Patron-in-Chief
International Center for Chemical and
Biological Sciences, University of Karachi-75270,
Pakistan
Tel: 111-222-292, Ext: 192
E-mail: [email protected]
Center for Bioequivalence Studies and Clinical
Research, PCMD.
Mr. Rizwan Ishaq
Financial Coordinator
Center for Bioequivalence Studies and Clinical
Research, PCMD, University of Karachi.
Tel: 111-222-292, Ext: 353, 509
021-37715067, 0345-8085400
E-mail: [email protected]
SCIENTIFIC SECRETARIES:
1) Ms. Sameen Shabbir
Tel: 0347-2093378
E-mail: [email protected]
2) Ms. Saima Khatoon
Tel: 0313-2126684
E-mail: [email protected]
3) Mr. Muhammad Irfan
Tel: 0333-2087833
E-mail: [email protected]
[email protected]
MEMBERS OF ORGANIZING COMMITTEE:
Javaid Riaz
Tahmina Adnan
Fahad Siddiqui
Tooba Shahab
ADDRESS FOR CORRESPONDENCE:
Kamran Khan
Rosina Asif
Dr. Muhammad Raza Shah
Talha Safdar
Sehrosh Naz Khan
Organizer
Shahrukh Khan
Namra Aijaz
Muhammad Ali
Kiran Wajid
S. M. Bilal Ali
Aasia Shaheen
Farhan Khan
Aasma Hashmi
Center for Bioequivalence Studies and Clinical
Research, PCMD, ICCBS University of Karachi
Karachi-75270, Pakistan
UAN: (+92-21) 111-222-292, Ext.233, 530
E-mail: [email protected]
Prof. Dr. M. Iqbal Choudhary H.I.,S.I.,T.I.
Director
International Center for Chemical and
Biological Sciences, University of Karachi-75270,
Pakistan
Tel: 111-222-292, Ext: 106
021 99261701, 99261702
E-mail: [email protected]