STERILE PRODUCTS INFRASTRUCTURE DESIGN AND TECHNOLOGICAL ADVANCES

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1 Controlled Release Society-Indian Chapter organizes National Seminar on STERILE PRODUCTS INFRASTRUCTURE DESIGN AND TECHNOLOGICAL ADVANCES September 14 th and 15 th, 2017 Venue: NIPER, Hyderabad Cosponsored by: NIPER, Hyderabad

2 About CRS IC. Controlled Release Society (CRS Inc.) with over 4000 members worldwide is an international organization for the promotion and development of novel drug delivery systems, with headquarters in Minneapolis, Minnesota, USA and liaison offices in Geneva, Switzerland and Kawasaki, Japan. The Indian Local Chapter of Controlled Release Society (CRSIC) was established in 1994 with headquarters at PERD Centre, Ahmedabad and regional office at SciTech Centre, Jogeshwari, Mumbai. The mission of CRSIC 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. For more details refer to the website: crsic.org About NIPER-Hyderabad. National Institute of Pharmaceutical Education and Research (NIPER) is an autonomous body established under the aegis of Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers as a Centre of Excellence for higher education, Research and Development in Pharmaceutical Sciences. NIPER-Hyderabad started its functioning as one of the six new NIPERs in 2007, in the premises of IDPL R&D centre, Balanagar, Hyderabad under the mentorship of Indian Institute of Chemical Technology, Hyderabad, a reputed R&D institute under CSIR. One of the objectives of NIPER-H is development of Human Resources for the ever growing Indian pharmaceutical industry. The state government has allocated land at Genome Valley for the development of the new NIPER campus. This new campus is surrounded by large number of Pharma and Biotech companies. A National Centre for Research and Development in Bulk Drugs (NCRDBD) is also being set-up in this new campus to cater to the R&D needs of the Bulk Drugs industry.

3 THEME OF THE SEMINAR Sterile dosage forms have always been an important class of pharmaceutical products in disease diagnosis, therapy and nutrition. Administration of drugs by parenteral route has skyrocketed over the past several years and will continue to do so. A primary explanation for this enormous growth lies with the advent of biotechnology, the products of which are biomolecules that cannot be readily administered by any other route because of bioavailability and stability reasons. Hence, it is safe to state that the number of injectable products being developed will significantly increase in the years to come. Perhaps by 2020, the market share of sterile drug products will approximately be the same as that for solid oral dosage forms. Keeping in mind the need of the hour, this workshop aims at educating and familiarizing the audience with the various aspects of developing and marketing sterile dosage forms. The seminar intends to cover a wide range of topics ranging from design of aseptic manufacturing facility to innovations in packaging of aseptic products and various novel sterile dosage forms. Regulatory understanding of sterile products would also be covered. The seminar will benefit students, academicians, researchers and industry personnel working with development, manufacture and marketing of sterile dosage forms.

4 Chief Guest: Dr. Chandrakant Kokate Vice Chancellor, KLE Deemed University, Belagavi, India. Keynote Address: Mr. Sudesh Shetty Partner Risk Consulting, Leads Life Sciences, KPMG, Mumbai, India Pharmaceutical Sector-Challenges and Opportunities SPEAKER Dr. Sunil Singhai President, Adept Pharma Consultants, Hyderabad Dr. Ajit Huilgol Process head, Bectochem Consultants and Engineers Pvt. Ltd., Mumbai, India Dr. Mangal Nagarsenkar Professor, Bombay College of Pharmacy, Mumbai, India Dr. Ankur Raval General Manager, Research and Development, Sahajanand Medical Technologies Pvt. Ltd. Mr. Siva Prasad Reddy BV Senior Technical Account Specialist- India, West Pharmaceutical Packaging India Pvt Ltd. TOPIC Design and Validation of Advanced Aseptic Manufacturing Facilities Detailed Engineering, Design and Technical Evaluation of Containment Systems Targeted Vesicular Systems- Ameliorating Barriers to Infectious Diseases and Cancer Drug Eluting Stents: Formulation Design and Advances Latest Trends in Injectable Development: A Packaging and Delivery Perspective

5 Technical Keynote Address: Ms. Michelle Frisch Managing Director, Centre of Process Excellence, Pennsylvania, USA Innovation Drives Process Equipment Design: Microsphere Classification, Filtration, and Drying in a Sterile Environment: SPEAKER TOPIC Mr. Manoj Kumar P. Head (Global Injectable Scientific Affairs), Mylan Laboratories, Mr. K. Chandra Shekhar CEO, LEIUTIS, Dr. Ashish Wadhwani Head (Pharmaceutical Biotechnology), JSS College of Pharmacy, Mysore, India Dr. Amit Srivastava FIC, ISOMED, Mumbai, India Mr. AVPS Chakravarthi Managing Director, Ecobliss India Pvt. Ltd., Dr. Devraj Rambhau Director, Pulse Pharma, Injectable Drug Delivery Platforms : Aseptic Process Engineering Challenges Insights on Design of Parenteral Depot Suspensions Development Process for Biologicals - Requirements and Infrastructure Design Radiation Sterilization Technology Innovation in packaging of sterile preparations Topic Awaited

6 ORGANISING COMMITTEE Dr. Anisha Pargal Global Clinical Science & Operations Director, Unilever R&D & Clinicals Site Leader, India Dr. Parizad Elchidana Independent Consultant GMP Scientific Inc. India Dr. T. Shekharam OSD, NIPER-H, Dr. Nalini Shastri Associate Professor, NIPER-H, Dr. Vandana Patravale Professor, Institute of Chemical Technology, Mumbai, India Dr. S. Chandrasekhar Mentor Director, NIPER-H, Hyderabad, India Prof. Ch. Sanjeeva Reddy Registrar, NIPER-H, Dr Ch Naveen Lecturer, NIPER-H, EXECUTIVE COMMITTEE Dr. H. L. Bhalla Dr. Anisha Pargal Dr. Vandana B. Patravale Dr. Hitesh Doshi Dr. Sujata Sawarkar Dr. Parizad Elchidana Dr. Ganga Srinivasan President Emeritus President Vice President Vice President Secretary Treasurer Member

7 Registration Guidelines Category Non Members Members Students Rs Rs Academicians Rs Rs Industry Rs Rs Students: Foreign Delegates USD 250 USD 150 Academicians: Foreign Delegates USD 400 USD 300 Last date for Registrations is 30 th August, 2017 Spot Registration is subject to availability; Registration is inclusive of service tax Payment Mode: Cheque or DD in favour of payable at Hyderabad NIPER, Hyderabad Kindly mention your name and contact number on the reverse side of the cheque/dd Post the registration form and DD/Cheque to the following address: Dr. Nalini Shastri, NIPER, 40, Dilip Rd, Jinkalwada, Balanagar, Hyderabad, Telangana , India. Mail the scanned copy of the form and cheque/dd to Membership Details Online membership application form available at: For more details on membership refer:

8 Poster Presentation Students, academicians and researchers are welcome to present their research related to the theme of the seminar at the poster presentation competition. Selection for the poster presentation is based on the abstracts submitted. Submission of Abstracts: All abstracts should be mailed to: Abstracts should not exceed the length of one A4 page. The abstracts should be structured and contain title (Top of the paper, centered, bold, all capital, Times New Roman, 14), name of authors (last name followed by initials, name of presenting author to be underlined, Times New Roman, 10), complete address of the institution including the state, country and pincode (Times New Roman, 10), ID of the presenting author, Key words (not more than 5, TNR, 10), aims, objectives, methodology, results and discussions, conclusions, references and acknowledgements. Use of graphs, tables and figures is strongly recommended. Leave a 1 inch margin on all 4 sides of the abstract Abstracts not abiding to the above mentioned formatting guidelines will be immediately rejected and not considered for the review process. Last date of submission of abstracts is 30 th July, 2017 Intimation of acceptance will be sent by 20 th August, 2017

9 Registration Form Please fill the attached Registration Form and post it along with the Bank Draft with your name written at the back of draft Kindly mention CRS Registration in bold letter on the envelope carrying the registration form. Kindly register at the earliest to avoid disappointment due to space constraints STERILE PRODUCTS INFRASTRUCTURE DESIGN AND TECHNOLOGICAL ADVANCES September 14 th and 15 th, 2017 Salutation: Mr./ Ms./ Mrs./ Prof./ Dr. Name: Surname First Name Middle Name Designation: Department/ Division: Company/ Institute: Address: City: State: Pin Code: Country: Mobile No.: ID: Payment Details Cheque/ DD No. Date: Name of the Bank: Branch: Amount:

Holding of National Conventions :

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