CRS INDIAN CHAPTER

Controlled Release Society (CRS Inc) with over 4000 members worldwide is
global scientific society. It is an international
CONTROLLED RELEASE SOCIETYINDIAN CHAPTER (CRS-IC)

ORGANIZES
ONE DAY NATIONAL SEMINAR
ON
CLINICAL APPROACH FOR DRUG DELIVERY SYSTEMS ADHERENCE TO REGULATORY REQUIREMENTS

promotion

organization

for

the

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

Saturday, 15th October 2016

chemical and biological delivery systems. It plans and organizes regularly symposia
and workshops that focus on advances in technology and business potential of

Supported By

Novel Drug Delivery Systems (NDDS). These activities have created increased

THE SCITECH CENTRE

awareness regarding the significance of novel drug delivery systems and

MUMBAI

appropriate utilization of such technology by both academic institutions and

Pharmaceutical industry.

VENUE :
SCITECH CENTRE
7, Prabhat nagar, Jogeshwari (W),
Mumbai-400 102,
Maharashtra, India.

Website: www.crsic.org

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.

THEME OF THE SEMINAR

SPEAKERS

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

Clinical approach for non solid oral drug delivery system

Mr. Sushrut Kulkarni
Senior Vice-President and Head Pharmaceutical Technology Center , Zydus Cadilla,
Ahmedabad, India

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

Clinical trials of oral drug delivery systems design requirements

Dr. Shravanti Bhowmik
Associate Vice President- Clinical Research
Sun Pharma Advanced Research Company, Mumbai, India

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.

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

WHO WILL BENEFIT

Executive Management

Consultants / Service Providers

Product Development Team

Compliance Information Managers

Regulatory Affairs Managers

Pharmacokinetic Experts

Clinical Researchers

Research students

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

WHAT THE SEMINAR WILL COVER

Plan now to attend this one day seminar as it is a rare opportunity to learn from the key Industry experts on todays hot topics.
Mr. Sushrut Kulkarni an inventor with a vast experience in development of

Dr Ganesh Jadhav responsible for product innovation will cover Nasal Drug

practically all dosage forms and holds around 143 patent applications filed globally

Delivery System: Scientific, Clinical and Regulatory Requirements for USA Market

will cover Clinical approach for non solid oral drug delivery system where he will

This non-traditional drug delivery route, offers a unique value proposition for drug

discuss the steps taken by FDA under Regulatory Science Initiatives to propose

developers to launch new products for the treatment of a range of acute and

Novel Bioequivalence study designs for complex solid oral and non-solid oral drug

chronic conditions. The presentation will provide a comprehensive view of various

delivery systems. These recommendations have greatly helped Industry to

intranasal drug delivery technologies available in the market as well as in the

understand FDA Perspective and to focus on critical aspects of development.

development. The scientific, clinical and regulatory requirements relevant for the
US market concerning ANDA and 505(b)(2) NDA products will be discussed

Dr. Shravanti Bhowmik with her expertise in Clinical Development will speak

extensively.

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

Mr. John Di Bella a biomedical engineer will be speaking on Applying Gastro Plus

of marketing approval will be discussed. The topic of her presentation is Clinical

PBPK modelling & simulation to assist with pharmaceutical research and

trials of oral drug delivery systems design requirements

regulatory submissions. Physiologically-based pharmacokinetic (PBPK) models

can be parameterized using a combination of in silico, in vitro, and in vivo data,

Dr. Mahesh Paithankar an expert on development of anticancer drug delivery

and their use, coupled with mechanistic absorption modelling (MAM), continues

system will cover Clinical Development strategies for cancer nano therapeutics

to increase within the pharmaceutical and generic industries as this technology

providing a detailed discussion with appropriate case studies related to nano-

helps to reduce R&D costs and regulatory burden. The focus of this presentation

therapeutic drug delivery systems on the key strategic aspects of clinical program

will be to discuss several case studies where GastroPlus modelling & simulation

like expected outcome, trial design, selection of primary endpoint, type of trial,

results were submitted to regulatory agencies to support waiver requests.

selection of appropriate listed Drug for 505(b)(2) program etc.

EXECUTIVE COMMITTEE

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. Munira Momin

Chairperson

Dr.Hitesh Doshi

Treasurer

Mr. Ajit Kanetkar

Co-chair

Dr. Munira Momin

Member

Dr. Ganga Srinivasan

Co-chair

Dr. Sujata Sawarkar

Member

Dr. Hitesh Doshi

Member

Dr.Parizad Elchidana

Invited Member

Dr. Sujata Sawarkar

Member

Dr. Prajakta Dandekar Jain

Invited Member

Dr. Ratnesh Jain

Member

Dr. Anil Pethe

Member

ADVISORY COMMITTEE

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 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.

Dr. Padma Devarajan

Dr. Kamalinder Singh

Mr. Naveen Sharma

Dr. Vandana B. Patravale

Mr. Harish Shah

Chief Operation Officer, Cliantha Research Limited

REGISTRATION DATES AND FEES

REGISTRATION FORM

Category

Non- 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

(by

Members
October 2016)

10th

ONE DAY NATIONAL SEMINAR ON

CLINICAL APPROACH FOR DRUG DELIVERY SYSTEMS ADHERENCE TO REGULATORY REQUIREMENTS

Note: Spot Registration subject to availability; Registration fee is inclusive of Service Tax

Saturday, 15th October 2016

Payment Mode
Demand draft to be made payable at Mumbai in favor of:
Controlled Release Society - Indian Chapter

(TO BE FILLED IN BLOCK LETTERS)

Salutation: Mr. /Mrs. /Ms. /Dr. /Prof.

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

REGISTRATION INFORMATION
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.

MEMBERSHIP INFORMATION
Online membership application form: http://goo.gl/forms/cMfIfXgZug
For more details on membership visit www.crsic.org/

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_________________ Date: ____________________

Amount: ___________ Drawn on Bank : __________________________

VENUE
SCITECH CENTRE
7, Prabhat nagar, Jogeshwari (W),
Mumbai-400 102, Maharashtra, India.