CRS INDIAN CHAPTER. Controlled Release Society (CRS Inc) with over 4000 members worldwide is global scientific society. It is an international

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1 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 , Maharashtra, India. Website: 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 Executive Management Product Development Team Regulatory Affairs Managers Clinical Researchers Consultants / Service Providers Compliance Information Managers Pharmacokinetic Experts 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

3 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 today s hot topics. 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 nanotherapeutic 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. 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 EXECUTIVE COMMITTEE Dr. Parizad Elchidana Chairperson Dr. Vandana Patravale Dr. Prajakta Dandekar Jain ORGANISING COMMITTEE Dr. H. L. Bhalla Dr. Anisha Pargal Dr. Vandana Patravale Dr. Ganga Srinivasan President Emeritus Acting President Vice President Secretary Dr. Munira Momin Chairperson Dr.Hitesh Doshi Treasurer Mr. Ajit Kanetkar Co-chair Dr. Munira Momin Dr. Ganga Srinivasan Co-chair Dr. Sujata Sawarkar Dr. Hitesh Doshi Dr.Parizad Elchidana Invited Dr. Sujata Sawarkar Dr. Prajakta Dandekar Jain Invited Dr. Ratnesh Jain Dr. Anil Pethe PATRONS ADVISORY COMMITTEE Mr. Pankaj Patel Mr. Dilip Sanghvi Dr Kiran Marthak Board and Global Head of Clinical Mr. Ajit Singh Mr. Kirti Patel Development- Lambda Therapeutic Research Ltd. Mr. Himadri Sen Mr. Amarjit Singh Dr. Indrani Banerjee Senior Manager, Academy for Clinical Excellence, Dr. Kamlesh Oza Dr. Anisha Pargal Dr. H. L. Bhalla Dr. Padma Devarajan Dr. Vandana B. Patravale Dr. F. V. Manvi Dr. Amrita Bajaj Dr. Manish Nivsarkar Dr. Kamalinder Singh Mr. Harish Shah 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

5 Category REGISTRATION DATES AND FEES Non- s (by 10 th October 2016) s (by 10 th 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 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 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: For more details on membership visit REGISTRATION FORM ONE DAY NATIONAL SEMINAR ON CLINICAL APPROACH FOR DRUG DELIVERY SYSTEMS - ADHERENCE TO REGULATORY REQUIREMENTS Saturday, 15th October 2016 (TO BE FILLED IN BLOCK LETTERS) Salutation: Mr. /Mrs. /Ms. /Dr. /Prof. Name: First Name Middle Name Last Name Qualification: Designation: Department/ Division: Company/ Institute: Address: City: State: Pin/ Zip Code: Country: Telephone: Fax: E mail ID: Payment Details D. D. No. Date: Amount: Drawn on Bank : VENUE SCITECH CENTRE 7, Prabhat nagar, Jogeshwari (W), Mumbai , Maharashtra, India.