Indian Society of Analytical Scientists (ISAS)-Hyderabad Chapter Analytical

Chemistry Division CSIR-Indian Institute of Chemical Technology

International Conference on

EMERGENT STRATEGIES FOR IMPURITY PROFILING

Co-Organized By

Raghu College of Pharmacy (RCP) Dakamarri, Bheemunipatnam (M)

Visakhapatnam-531162 Andhra Pradesh, India

at Raghu College of Pharmacy

16-17, July 2016

Science & Engineering Research Board Department of Science & Technology

Government of India

Sponsored by

Advisory committee Mr. Kalidindi Raghu, Chairman, Raghu Educational Society Dr. Jagadeesh Panda, Principal, Raghu College of Pharmacy Dr. R. Nageswara Rao, Former Head, Analytical Chemistry Division, CSIR-IICT Prof. Veerabhadraiah,  Dean, Raghu Educational Institutions Prof. D. Gowri Shankar, A.U. College of Pharmaceutical Sciences, Andhra University Prof. K.V. Ramana Murthy, A.U. College of Pharmaceutical Sciences, Andhra University

Local Organizing Committee Chief Patron: Mr. Kalidindi Raghu, Chairman, Raghu Educational Society Patron: Mrs. Kalidindi Ramadevi, Secretary, Raghu Educational Society Convener: Dr. Jagadeesh Panda, Principal, RCP Co-Convener: Dr. R. Nageswara Rao, CSIR-IICT Members: Dr. Prafulla Kumar Sahu, RCP (Co-ordinator/ Scientific/ Souvenir) Dr. Chandra Sekhar Patro, RCP (Scientific/ Accounts) Mr. Y.V.V. Jogendra Kumar, RCP (Souvenir/ Accounts) Mr. Sri Rama Murthy Pyla, RCP (Transport/ Hospitality) Mrs. K. Padmaja, RCP (Transport/ Hospitality) Mr. Sarada Prasad Sarangi, RCP (Transport/ Hospitality) Ms. A. Deepika, RCP (Hospitality) Mrs. R. N. Kavitha, RCP (Press/ Auditorium) Mrs. Anita Raj Panigrahi, RCP (Press/ Auditorium) Ms. M. Amala, RCP (Registration/ Auditorium) Mrs. Mary Sulakshana, RCP (Registration) Mrs. Arnnapurna Dash, RCP (Registration) Mrs. Sirisha Panda, RCP (Registration) Ms. V. Rajeswari, RCP (Registration)

Speakers Prof. Teresa Cecchi, Ph. D., ITT MONTANI, Fermo FM, Italy Prof. Gerhard K. E. Scriba, Ph. D., University of Jena, Philosophenweg, Jena, Germany Dr. R. Nageswara Rao, Former Chief Scientist, Analytical Chemistry Division, CSIR-IICT, India Prof. P. Nageswara Rao, NIT, Warangal, Andhra Pradesh, India Prof. D. Gowri Shankar, A.U. College of Pharmaceutical Sciences, Andhra University, India Prof. K.V. Ramana Murthy, A.U. College of Pharmaceutical Sciences, Andhra University Dr. Kanna Rao, Principal Scientist, Novartis, India Dr. T.S.V.S. Gopala Krishna, General Manager-Validation, Hospira, India

DST-SERB SPONSORED INTERNATIONAL CONFERENCE

Registration Fee Up to

25th Jun. 2016 Up to 10th Jul. 2016

Spot Registration

Students Rs. 750/- Rs. 850/- Rs. 1000/- Faculty/ Ph.D. Scholars Rs. 1000/- Rs. 1200/- Rs. 1500/- ISAS Members Rs. 1000/- Rs. 1200/- Rs. 1500/- From Industry Rs. 1500/- Rs. 1800/- Rs. 2000/-

About RCP

Visakhapatnam is a coastal, port city, often called "The Jewel of the East Coast", situated in Andhra Pradesh, located on the eastern shore of India, nestled among the hills of the Eastern Ghats and facing the Bay of Bengal to the east. It is the second largest city in Andhra Pradesh with an area of 550 km², it is primarily an industrial city, apart from being a port city. It is also home to the Eastern Naval Command. Visakhapatnam has been selected as one of the hundred Indian cities to be developed as a smart city under PM Narendra Modi's flagship Smart Cities Mission. The city became a global destiny for more than 100 manufacturers of bulk drugs, active pharmaceutical ingredients, and intermediates with world class Jawaharlal Nehru Pharma City spread over 2400 acres. Visakhapatnam's beaches (such as Ramakrishna Mission Beach and Rushikonda), parks (such as Kailasagiri and VUDA Park), museums (such as the Kursura Submarine Museum and Visakha Museum), and proximity to areas of natural beauty (such as the Kambalakonda Wildlife Sanctuary, Araku Valley, and Borra Caves) have helped the city become a significant tourist destination.

Scope of the Seminar Quality, purity, safety and efficacy of drugs and pharmaceuticals are the fundamental issues of importance in

new drug development and always demand significant improvements. A greater emphasis is being paid on monitoring and controlling the impurities and degradation products to assure the quality and safety of drugs worldwide. Hence, RCP proposes to organize a two-day International Conference, on “EMERGENT STRATEGIES FOR IMPURITY PROFILING” on 16th-17th of July 2016, in association with Indian Society of Analytical Scientists (ISAS)- Hyderabad Chapter. Presence of impurities, the undesired substances in the bulk drug material and its dosage forms greatly diminish both drug quality and safety. By the identification (characterization) and quantification of the impurities and related substances, the risk of their contribution to the side effect profile of the drug therapy can be avoided or minimized. Moreover, the characterization of such trace to minor analytes in the final product is the inherent prerequisites in the wake of stringent requirements from the regulatory authorities. As pharmaceutical industry continues to demand for extraordinary technological advances, it is very important that specialized studies in this area are required. In the present conference, the deliberations will focus on the advanced instrumental technologies and strategies to identify and control the impurities in pharmaceuticals. A forced degradation study (stress testing) is the essential tool used to predict stability problems. Stress testing and stability indicating analytical procedures provide data to support the characterization of potential degradants; degradation pathways and intrinsic stability of the drug molecule. Forced degradation and impurity profiling is one of the key prerequisites for investigational new drug (IND) and new drug application (NDA) registration. Moreover, this seminar will create a forum to bring together scientists, pharmaceutical manufacturers, young researchers and technologists to discuss the issues on this topic. It will also provide an excellent opportunity to the student participants and research scholars to learn the recent developments and future advancements on various allied themes like, stability of drugs and pharmaceutical products; global regulatory status and pharmacopoeial requirements of stress studies; strategies of impurity profiling; Quality by Design (QBD); etc. The themes are multidisciplinary and covers entire scope of Pharmaceutical Sciences and the Conference on the topic will bring wide attention globally. The technical program includes invited lectures, oral and poster presentation of research papers.

Raghu College of Pharmacy (RCP), Visakhapatnam; a premium institute situated in the region of coastal Andhra Pradesh. RCP was founded in 2007 under the generous management of Raghu Educational Society with the mission to foster a conducive environment for higher learning in Engineering, Pharmacy and Management. The main thrust of RCP has been to train qualified professionals in the field of pharmacy to cater the needs of the society and to shoulder the ever-changing bussiness responsibilities at national and international levels. The campus of RCP is located at Dakamarri Village, Bhimili Mandal, Visakhapatnam District (A.P.), in a tranquil atmosphere amidst gardens and greenery. The college has developed good infrastructure consisting of 0.25 lakh sq.ft build-in area to house classrooms, laboratories, library, staff rooms, administrative office, hostels, etc. After successful conduct of 4 National Conferences, RCP is proud to announce the 1st International Conference: “EMERGENT STRATEGIES FOR IMPURITY PROFILING”, going to be scheduled from 16th-17th July 2016 in association with Indian Society of Analytical Scientists (ISAS)- Hyderabad Chapter.

About ISAS

About Visakhapatnam

ISAS – Hyderabad chapter was established in1988 with the aim to disseminate the latest developments and also exchange scientific information pertaining to the growth of the Analytical Sciences. It has now 13 chapters with more than 2500 life members spread all over India. Its activities in promotion of science and research in general and the analytical areas in particularly continued to grow steadly over the years by the way of conducting seminars, conferences, symposia and workshops in various areas of analytical chemistry. It provides scientific information to academics, scientists, industries, students and R & D institutions, etc. ISAS-Hyderabad Chapter is established under the care of Analytical Chemistry Division, CSIR-Indian Institute of Chemical Technology (CSIR-IICT), Hyderabad, India as one of the oldest societies to promote R & D in the analytical sciences.

DST-SERB SPONSORED INTERNATIONAL CONFERENCE

Call for Papers We would like to invite scientists, scholars, young researchers and technologists from industries and academics to participate in the conference. We wish to encourage all participants to present their original contributions during both oral and poster sessions in the entire scope of pharmaceutical sciences. Send your 2 pages extended abstract (12 point font, Times New Roman, double line space, 1.00” margins all side) to mail: rcpconference2016@gmail.com or raghucollegeofpharmacy@rediffmail.com. The abstract should include Title, Authors name & Affiliation, Background, Method, Results & Discussion, Conclusion, Tables and Figures (black & white or grey/ 300 dpi). Contact Nos: +91-8121139575 or 8331887509 or 9550745315.

Important Dates Fee April 25, 2016 Call for Abstracts open

June 25, 2016 Abstracts Submission Deadline June 25, 2016 Early-Bird Registration Deadline June 30, 2016 Notification of Abstracts Status

July 16-17, 2016 Conference

CO-­‐ORGANIZED  BY