One Day National Seminar On “ Clinical Approach for Drug delivery Systems - Adherence to Regulatory Requirements"

1. CRS INDIAN CHAPTER
CONTROLLED RELEASE SOCIETY-
INDIAN CHAPTER (CRS-IC)
ORGANIZES
ONE DAY NATIONAL SEMINAR
ON
CLINICAL APPROACH FOR DRUG DELIVERY SYSTEMS -
ADHERENCE TO REGULATORY REQUIREMENTS
Saturday, 15th October 2016
Supported By
THE SCITECH CENTRE
MUMBAI
VENUE :
SCITECH CENTRE
7, Prabhat nagar, Jogeshwari (W),
Mumbai-400 102,
Maharashtra, India.
Website: www.crsic.org
Controlled Release Society (CRS Inc) with over 4000 members worldwide is
global scientific society. It is an international organization for the
promotion and development of novel drug delivery systems, with the
headquarters in Minneapolis, Minnesota, USA and liaison offices in Geneva,
Switzerland and Kawasaki, Japan. The Indian Local Chapter of Controlled
Release Society (CRS-IC) was established in 1994 with headquarters at PERD
Centre, Ahmedabad and regional office at SciTech Centre, Jogeshwari, Mumbai.
The mission of CRS-IC is to promote education, create awareness and to
encourage scientific research towards the creation of intellectual wealth in the
area of drug delivery systems in India. The CRS-IC works with the objective of
providing an excellent forum to advance the science and technology of new
chemical and biological delivery systems. It plans and organizes regularly symposia
and workshops that focus on advances in technology and business potential of
Novel Drug Delivery Systems (NDDS). These activities have created increased
awareness regarding the significance of novel drug delivery systems and
appropriate utilization of such technology by both academic institutions and
Pharmaceutical industry.
The CRS-IC offers opportunities for business collaborations with technology driven
pharmaceutical manufacturers and allied industry. It provides a platform for
interaction with emerging drug delivery designers and biotechnology companies,
pharmaceutical excipients and equipment manufacturers and allied suppliers to
expose their concepts, technological products and services. CRS-IC offers travel
grants to students and young scientists to enable them to participate and present
their research work at international platforms.

2. THEME OF THE SEMINAR
The interest in Novel Drug Delivery Systems (NDDS) has increased due to advancement and
availability of variety of technologies to deliver conventional drugs in novel dosage forms.
However the clinical approach and the regulatory requirements continue to provide a
major challenge. Developing NDDS for an existing molecule is a part of the Research and
Development portfolio for most Pharmaceutical Companies, in a quest of delivering
therapeutic agents with improved efficacy and minimum side effects.
This seminar will provide a forum for academic and industry researchers, clinical experts
and regulatory professionals to discuss the latest scientific and clinical developments for
drug delivery systems, as well as the perceived regulatory concerns and challenges
regarding their submission and approval. Delivery Systems presented will cover oral,
transdermal, nasal and injectables. Some non-clinical opportunities with respect to
modelling and simulation, to assist with pharmaceutical research and regulatory
submissions, will also be discussed.
WHO WILL BENEFIT
SPEAKERS
Clinical approach for non solid oral drug delivery system
Mr. Sushrut Kulkarni
Senior Vice-President and Head Pharmaceutical Technology Center , Zydus Cadilla,
Ahmedabad, India
Clinical trials of oral drug delivery systems – design requirements
Dr. Shravanti Bhowmik
Associate Vice President- Clinical Research
Sun Pharma Advanced Research Company, Mumbai, India
Clinical development strategies for cancer nano – therapeutics
Dr. Mahesh Paithankar
Senior Vice-President, NDDS, Intas Pharmaceuticals Ltd., Ahmedabad, India
Nasal drug delivery system: scientific, clinical and regulatory requirements for
USA market
Dr. Ganesh Jadhav
General Manager, Product Innovation
Sun Pharmaceutical Industries Ltd., Vadodara, India
Applying gastro plus PBPK modeling & simulation to assist with pharmaceutical
research and regulatory submissions
Mr. John Di Bella
Vice President – Marketing & Sales at Simulations Plus, Inc., California, USA
Executive Management
Product Development Team
Regulatory Affairs Managers
Clinical Researchers
Consultants / Service Providers
Compliance Information Managers
Pharmacokinetic Experts
Research students

3. WHAT THE SEMINAR WILL COVER
Mr. Sushrut Kulkarni an inventor with a vast experience in development of
practically all dosage forms and holds around 143 patent applications filed globally
will cover “Clinical approach for non solid oral drug delivery system” where he will
discuss the steps taken by FDA under “Regulatory Science Initiatives” to propose
Novel Bioequivalence study designs for complex solid oral and non-solid oral drug
delivery systems. These recommendations have greatly helped Industry to
understand FDA Perspective and to focus on critical aspects of development.
Dr. Shravanti Bhowmik with her expertise in Clinical Development will speak
about the major concerns of efficacy and safety with new oral drug delivery
system which may require extensive clinical trials or preclinical studies. A case
study of an oral controlled release product that was clinically developed to a stage
of marketing approval will be discussed. The topic of her presentation is “Clinical
trials of oral drug delivery systems – design requirements”
Dr. Mahesh Paithankar an expert on development of anticancer drug delivery
system will cover “Clinical Development strategies for cancer nano – therapeutics”
providing a detailed discussion with appropriate case studies related to nano-
therapeutic drug delivery systems on the key strategic aspects of clinical program
like expected outcome, trial design, selection of primary endpoint, type of trial,
selection of appropriate listed Drug for 505(b)(2) program etc.
Plan now to attend this one day seminar as it is a rare opportunity to learn from the key Industry experts on today’s hot topics.
Dr Ganesh Jadhav responsible for product innovation will cover “Nasal Drug
Delivery System: Scientific, Clinical and Regulatory Requirements for USA Market “
This non-traditional drug delivery route, offers a unique value proposition for drug
developers to launch new products for the treatment of a range of acute and
chronic conditions. The presentation will provide a comprehensive view of various
intranasal drug delivery technologies available in the market as well as in the
development. The scientific, clinical and regulatory requirements relevant for the
US market concerning ANDA and 505(b)(2) NDA products will be discussed
extensively.
Mr. John Di Bella a biomedical engineer will be speaking on “Applying Gastro Plus
PBPK modelling & simulation to assist with pharmaceutical research and
regulatory submissions”. Physiologically-based pharmacokinetic (PBPK) models
can be parameterized using a combination of in silico, in vitro, and in vivo data,
and their use, coupled with mechanistic absorption modelling (MAM), continues
to increase within the pharmaceutical and generic industries as this technology
helps to reduce R&D costs and regulatory burden. The focus of this presentation
will be to discuss several case studies where GastroPlus™ modelling & simulation
results were submitted to regulatory agencies to support waiver requests.

4. SCIENTIFIC COMMITTEE
Dr. Parizad Elchidana Chairperson
Dr. Vandana Patravale Member
Dr. Prajakta Dandekar Jain Member
ORGANISING COMMITTEE
Dr. H. L. Bhalla President Emeritus
Dr. Anisha Pargal Acting President
Dr. Vandana Patravale Vice President
Dr. Ganga Srinivasan Secretary
Dr.Hitesh Doshi Treasurer
Dr. Munira Momin Member
Dr. Sujata Sawarkar Member
Dr.Parizad Elchidana Invited Member
Dr. Prajakta Dandekar Jain Invited Member
Dr. Munira Momin Chairperson
Mr. Ajit Kanetkar Co-chair
Dr. Ganga Srinivasan Co-chair
Dr. Hitesh Doshi Member
Dr. Sujata Sawarkar Member
Dr. Ratnesh Jain Member
Dr. Anil Pethe Member
PATRONS
Mr. Pankaj Patel Mr. Dilip Sanghvi
Mr. Ajit Singh Mr. Kirti Patel
Mr. Himadri Sen Mr. Amarjit Singh
Dr. Kamlesh Oza Dr. F. V. Manvi
Dr. Anisha Pargal Dr. Amrita Bajaj
Dr. H. L. Bhalla Dr. Manish Nivsarkar
Dr. Padma Devarajan Dr. Kamalinder Singh
Dr. Vandana B. Patravale Mr. Harish Shah
Dr Kiran Marthak Board Member and Global Head of Clinical
Development- Lambda Therapeutic Research Ltd.
Dr. Indrani Banerjee Senior Manager, Academy for Clinical Excellence,
Mumbai
Ms. Chandrika Arora Founder & CEO , QMATRA Services LLP
Dr. Hrishikesh Kulkarni Senior Manager - Medical Services, Glenmark
Pharmaceuticals Ltd.
Mr. Naveen Sharma Chief Operation Officer, Cliantha Research Limited
EXECUTIVE COMMITTEE
ADVISORY COMMITTEE

5. Category
Non- Members
(by 10th October 2016)
Members
(by 10th October 2016)
Students 750 INR 500 INR
Academicians 1000 INR 750 INR
Industry 2000 INR 1000 INR
Foreign Delegates: Students 400 USD 300 USD
Foreign Delegates: Academicians 600 USD 500 USD
Note: Spot Registration subject to availability; Registration fee is inclusive of Service Tax
• Please fill the attached Registration Form and post it along with the Bank
Draft/Cheque with your name written at the back of draft/cheque.
• Kindly mention ‘CRS Registration’ in bold letter on the envelope carrying the
registration form.
• Register at the earliest to avoid last minute disappointment due to space
constraints.
• Students are requested to enclose a letter from the head of institution certifying
their student status.
• Photocopies of the Registration Form may be used.
• No refund of Registration Fee in case of cancellation.
Payment Mode
Demand draft to be made payable at Mumbai in favor of:
Controlled Release Society - Indian Chapter
Mail the Registration Form and Fee to:
Prof. Vandana B. Patravale
A-255, Department of Pharmaceutical Sciences and Technology
Institute of Chemical Technology, Matunga (East), Mumbai-400 019
Email ID: patravale.vb@gmail.com
ONE DAY NATIONAL SEMINAR ON
CLINICAL APPROACH FOR DRUG DELIVERY SYSTEMS -
ADHERENCE TO REGULATORY REQUIREMENTS
Saturday, 15th October 2016
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SCITECH CENTRE
7, Prabhat nagar, Jogeshwari (W),
Mumbai-400 102, Maharashtra, India.
Online membership application form: http://goo.gl/forms/cMfIfXgZug
For more details on membership visit www.crsic.org/
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