is pleased to Invite Chemists of

the Bio Analytical Field to participate

in a one-day Seminar on

CHROMATOGRAPHIC SOCIETY OF INDIACHROMATOGRAPHIC SOCIETY OF INDIA

Venue: Lecture Theater, Third Floor

Centre For Excellence in

Telecom Technology and Management (CETTM),

MTNL Management Training Institute, Technology Road,

Opposite Hiranandani Hospital & IBS Building,

Hiranandani Gardens, Powai, Mumbai - 400 076.

on Tuesday, November 8th, 2011on Tuesday, November 8th, 2011

Recent Trends, Challenges and Solutions in Bio Analysis- (Lecture Schedule)

Registration Details:

Fee for employees of Government Insti tutions and Students: ` 1000

Fee for employees of Private Industries and CROs. ` 2000

(The Life Members and Corporate Members will be eligible for 10% Discount. The Registration

fee is inclusive of Service Tax and will cover the cost of tui tion, materials, lunch & tea)

Please use the enclosed form for registration or do i t through E-mail: info@chromsocindia.org

or website: www.chromsocindia.org

For more information, please contact Ms. Renita Aposta in the following address :

Chromatographic Society of India

219 Mastermind-1, Aaarey Milk Colony

Goregaon (East), Mumbai - 400 065

Phone/Fax : +91 22 28797522

Topic Speaker Time

Welcome Address

Dr.G.Ramakrishnan, President, CSI

9.30 AM

Tributes to Guest of Honor - Dr. R.T. Sane

Dr. Sasikumar Menon, Director, Therapeutic Drug Monitoring Laboratory, Mumbai

9.35 AM

Addressing the gathering by Guest of Honor

Dr R. T. Sane, Honorary Director, GNIRD,G. N. Khalsa College, Matunga, Mumbai

9.45 AM

Challenges of Incurred Sample Analysis Requirements and Managing

ISR Regulated Bio Analysis-

with Case Studies

Dr. Rajesh M Karwa, Vice President, Pharmacokinetics, Glenmark Generics, Mumbai

10.15 AM

Tea Break

11.00AM

Challenges of Matrix Ef fects in Bio-analysis and how to overcome the same-with case studies

Dr. Manish Yadav, Head, CRO, Cadila Pharmaceuticals, Ahmedabad

11.30 AM

Guidelines for Regulated Bio Analysis –

Present and Future Challenges

Dr. Shrinivas Savale, General Manager, B.E Center, Torrent Pharmaceuticals, Ahmedabad

12 .15 PM

Lunch 1.00 PM

Method transfers, Par tial Validation vs Full Validation in regulated Bio Analysis

Dr. Ashutosh Pudage, President, Analy tical Services, Accutest Research Laboratories, Mumbai

2 .00 PM

Instrumentation and Method Validation Challenges in Bio Analysis and how to mitigate Validations Risks

Mr.G.Sundar, Assistant General Manager, QA, Audits & Compliance, Alkem, Daman

2.45 PM

Tea Break

3.30 PM

Advantages of Network in Bio Aanalysis for Productivi ty, Cost Reduction and Bet ter Compliance

Mr. Sudhakar Kasturi, Business Consultant, Informatics-APAC Region, Thermo Fisher

Scientific, Mumbai

4.00 PM

Question & Answer , discussions Moderator Dr. Sas ikumar Menon 4.45 PM

Concluding Remarks and closing of the Seminar Dr. G. Ramakrishnan 5.00 PM

Arrival of guests and Delegates registration --------- 9 AM onwards

Indian pharmaceutical industry was predominantly into generics production and research till

1990s. It rose in the global market in mid '90s with the improvement in quali ty of products by

adapting global standards and processes and being the early adapters of changing regulatory

requirements. The leading edge in production and global competi tion gave the oppor tunity for

domestic pharmaceutical companies to explore the possibili ties of strengthening locally, the

other par ts of the pharmaceutical value chain.

Bio Analysis, a specialized area of pharmaceutical value chain gained momentum in the early

2000 in India. It has since steadily grown with many Indian Pharmaceutical companies investing

in i t, to innovate and improve the quali ty of drugs they manufacture. With the Government's

favorable policies for impor ts of necessary instruments like HPLCs, LCMSMS instruments and

consumables, infrastructure for the Bio Analy tical laboratories met the international standards.

The global pharmaceutical companies quickly discovered the advantage of outsourcing this

service to India, which could deliver the results with international quali ty at a cost advantage.

The arrival of multiple Clinical Research Organizations increased the visibili ty of the talent

available in India with quali ty and timely results to the global pharmaceutical companies.

With a sizeable population of English speaking, talented scientists, awareness of regulatory

guidelines and a strong team of exper ts leading the organizations, India's Bio Analy tical

workspace has become the most sought af ter destination with China closely following up.

To keep the leadership position, i t is impor tant to be aware of the challenges that the industry is

facing today, expected to face in future and be prepared for them. Today's challenges are

dif ferent from those that existed just five years ago. Hence to be successful and profi table, one

needs to constantly align and re-align to the market expectations and the regulatory

requirements. It is impor tant that the present and future generation of Bio Analysts is impar ted

with knowledge on these issues and is prepared for these situations.

Chromatographic Society of India feels that there is an urgent and genuine need for exchange of

ideas on challenges in chemistry and technology including instruments and sof tware, sharing

the challenges faced and how the issues are resolved, creating awareness about newer and

stricter regulatory guidelines, dissemination of information about various tools and technologies

that improve productivi ty, reduces human error and understanding the Quali ty Assurance. CSI

believes that this seminar will help to inter face the exper ts of the Bio Analy tical area with

aspiring young Bio Analy tical chemists and students that will immensely help the future of the

Bio Analy tical industry in India to stay ahead of other countries.

About the SeminarAs Chromatographic Society of India is a non-profi t educational organization, the key driver of

this event is to impar t knowledge, sharing the experience of the exper ts in the field. This one day

seminar is our at tempt to bring the exper ts from the field of Bio Analysis and of fer the plat form

for purely scientific discussions, exchange of ideas and improve the skills of the practsing

chemists. The exper ts come from Bio Analy tical industry and the topics they would cover are

current hot topics in the domain. Details about the speakers and the topics are given in the back

page this brochure.

Felicitation to Professor (Dr) R.T.Sane. On the occasion of this seminar, CSI is pleased to felici tate Dr. R. T. Sane, who has contributed to

the Bio Analy tical field immensely. He is presently the Honorary Director of Gurunanak Insti tute

of Research and Development, in G N Khalsa College, Matunga. Prior to this, Dr R T Sane was the

Principal of the Shikshana Prasaraka Mandali's Ramnarain Ruia College, Matunga for 13 long

years. He has conscientiously functioned in the capaci ty of a dedicated teacher and research

guide during the last four decades. He has been one of the early adapters in the area of Bio

Analy tical research and has guided 31 M.Sc. and 119 Ph.D. students so far in varied fields of

Bioanaly tical Sciences. His research work has resulted in more than 280 publications in

reputed journals. Many of his students today occupy positions of high responsibili ty in various

known pharmaceutical and other establishments. He has contributed significantly in enhancing

the knowledge and skill levels in the Pharmaceutical Analy tical Chemistry. He has been an

impor tant Advisor to University of Mumbai and has taken active role in the designing several

innovative academic curricula. Recently, under his guidance the Depar tment of Science &

Technology, Gov t. of India has sanctioned a grant of Rs. 5 Crores for establishing the "National

Facility for bio pharmaceuticals human resource development in bio pharmaceutical

production"

Chromatographic Society of India is heavily indebted to Dr. R.T.Sane for his involvement in its

welfare right from its inception in the year 2000. He has played a key role in bringing the

American Chemical Society Shor t Course in Capillary Gas Chromatography and HPLC into India

for the first time in October 2000 in Mumbai. He has also been a guiding factor in the activi ties of

CSI from time to time. CSI is pleased to felici tate him in a befi t ting fashion for his Lifetime

Contributions in Teaching, Research and Administration during this seminar. As a special

gesture, CSI will be inviting all his postgraduate and Doctoral students for the felici tation

function.

CHROMATOGRAPHIC SOCIETY OF INDIA219 Mastermind I, Royal Palms Aarey Milk Colony, Goregaon (E) Mumbai - 400 065.Telefax : +91 22 2879 7522 info@chromsocindia.org www.chromsocindia.org• •

REGISTRATION FORMOne-day Seminar on

Recent Trends, Challenges and Solutions in Bio Analysis

My Contact Details are:

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Mailing Address:

Phone: Fax:

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Please send by Registered Post or courier this form duly filled in with all details

and the Crossed Demand Draft or cheque drawn in favor of “Chromatographic

Society of India” to the address mentioned above.

Please email this form duly filled to info@chromsocindia.org for advance registration, which should be followed by sending the Printed Form & Cheque for completing the registration.

Employees

Employees `

of Government Insti tutions and Students: ` 1000

of Private Industries and CROs. 2000

(The Life Members and Corporate Members will be eligible for 10% Discount. The Registration fee is inclusive of Service Tax and will cover the cost of tui tion, materials, lunch & tea )

November 8th, 2011, MTNL Management Training Institute, Mumbai

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