Dia Conference Merriot 10-11 Feb 2012

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Chemistry, Manuacturing and Controls (CMC) is one o the three

areas that health authorities consider or the review and approvalo drug applications. Efective CMC strategies and execution may

reduce regulatory burden, enable shorter review times, and support

post approval maintenance.

Lg ObjvsAt the conclusion o this workshop, participants will be able to:

• Describekeyconceptsinthebusiness,technicalandexecution

applicationsofregulatoryCMC

• Demonstrateprocessunderstanding,riskassessmentandquality

systems

• Understandtheimportancesandemergingtrendsinelectronic

submissionsanddocumentmaintenance

• Translatethedevelopmentofproductknowledgeintoeective

regulatorysubmissioncontent

• Enhancetheirorganizations’currentstrategiesforsuccesstechnical-

regulatoryllings

All attendees will receive a DIA Certicate of Attendance

at the conclusion of the event.

CMC: Converting Science into

Regulatory Submission

ID# 12660 February 10-11, 2012

Ahmedabad, India

RRAM C-CHAIRS

H. G. KoshiaCommissionerFDCA, ujarat

Nandkumar Chodankarroup CE

harma Business Excel Industries Limited

RRAM CMMITTEE

Y. D. ChauhanJoint Commissioner

FDCA, ujarat

R. L. VaishyaJoint Commissioner

FDCA, ujarat

Dr A. RamkishanAssistant Drug Controller (India)

CDSC, UJARAT

Shrenik Shah

DirectorMontage Labs

R. R. TuljapurkarSenior Vice resident, CQA

Cadila Healthcare

Jigar PatelVice Chair

DIA - Young roessional Chapter, ujarat

ndia Ofce

Drug Information Association

303, Wellington Business Park I

Andheri-Kurla Road, Marol

Andheri East, Mumbai 400059

Worldwide Headquarter

Drug Information Association, Inc.800 Enterprise Road, Suite 200

Horsham, PA 19044, USA

eional Ofce

Basel, Switzerland Tokyo, Japan Mumbai, India

Beijing, China

PROGRAM CO-CHAIRS

H. G. Koshia

CommissionerFDCA, ujarat

Nandkumar Chodankar

roup CEharma BusinessExcel Industries Limited

KEYNOTE SPEAKER

Pankaj R. Patel

Chairman and Managing

Director

Zydus Cadila



2

9:15-10:00 am

Opning CmonyH G KoshiaCommissioner

FDCA,Gujarat

Nandkumar ChodankarGroupCEO

PharmaBusinessExcelIndustriesLimited

Kynot Addss

Pankaj R. PatelChairmanandManagingDirector

ZydusCadila

10:00-10:20 am TeA / COffee BreAK

10:20-11:00 am

Analytical Mtod Dvlopmnt ding PodctDvlopmnt

Aniruddha VaidyaDirector

AnalyticalSolutions

11:00-11:40 am

Podct Dvlopmnt Statgy basd on QBDPincipls

Pratibha PilgaonkarFounderandCEO

Rubicon

11:40 am-12:20 pm

Dsign o expimnt

Dr. Mukesh GohelDirector

PostgraduateStudiesintheSchoolofLifeSciences

AhmedabadUniversity,Ahmedabad

12:20-1:20 pm LuCh

1:20-2:00 pm

Callngs o CMC and Manacting: Indian

PspctivK AnandChiefOperatingOcer

Famycare

2:00-2:40 pm

Dcincis idntid by rglatoy application*Rajinder SinghDirector,RegulatoryAairs

Ranbaxy

2:40-3:00 pm TeA / COffee BreAK

3:00-3:30 pm

Vndo QalicationDr. Ruchika RavalPresident

GlobalBiopharmRegulationsInc.

3:30-4:00 pm

Pocss Analytical Tcnology

Parag DasGeneralManager

TorrentPharmaceuticals

4:00-4:30 pm

CMC pdats om uS fDA

Alpesh PatelVicePresidentRegulatoryAairs

AmnealPharmaceuticals

4:30-5:00 pm PAeL DISCuSSIO

Moderator

Nandkumar ChodankarGroupCEO


DA1| FRDA, FRAR 10, 2011



3

9:00-9:30 am

risk basd appoac to rglatoy Assssmnto Qality (IChQ9)

G GurudattaCOOandDirector

SemlerResearch

9:30-10:00 am

Complianc Isss: fDA Pspctiv

Vinay Nayak

PresidentAlembicPharma

10.00-10.30

Pamactical Qality Systm and Basic Pinciplso GMP

Dr A RamkishanAsst.DrugsController(I)

ZonalOce,Ahmedabad,CDSCO

10:30-11:00 am TeA / COffee BreAK

11:00-11:30 pm

ICh Q11: Dvlopmnt and Manact o Dg

SbstancsRajiv DesaiPresident-Quality

DishmanPharmaceuticalsandChemicalsLimited

11:30 am-12:00 pm

Simplication and Optimisation to dc t

cost and timNandkumar ChodankarGroupCEO


12:00-12:30 pm

Scal p o Lyopilization Pocsshavesh PatelGeneralManager-FnD

AstronResearch

12:30-1:30 pm LuCh BreAK

1:30-2:00 pm

Pocss ValidationR R TuljapurkarSeniorVicePresident-Quality

ZydusCadila

2:00-2:30 pm

Analytical Mtod ding Podct Dvlopmnt(Cas Stdis)

Antony Raj GomesSeniorVicePresident

Mylan

2:30-3:15 pm

Tcnology Tans Callngs, Analytical MtodTans (Cas Stdis)

Sanjay KapadiyaHead-QA&RC

Appotex

3:15-3:45 pm TeA / COffee BreAK

3:45-4:30 pm PAeL DISCuSSIO

Moderator

H G KoshiaCommissioner

FDCA,Gujarat

4:30-5:00 pm COfereCe ADjOureD

DA2| SATRDA, FRAR 11, 2012



PLAS CONSDR THS FORM AS AN NVOC

CMC: Converting Science into Regulatory Submission

Meeting .D. # 12660 – February 10-11, 2012 – Country nn and Suites y Carlson, Ahmedabad, ndia

TRAVL AND HOTL

Attendeesshouldmakeairlinereservationsasearlyaspossibletoensureavailability.

Single NR 3500 + taxes

The rates Include: Accommodations, Room Taxes, Internet,

Two way airport transers, Bufet Breakast

CountryInnandSuitesByCarlsonislocatedatSurdharaCircle,ODrive-InRoad,

AhmedabadGujarat380054,India.Phone:079.30112244,Fax:079.30112233

Contact Person:RahulChawda,email:[email protected]

MTNG CONTACTS

MTNG MANAGR: Manoj Trivedi,SeniorManager

MarketingandProgramDevelopment,DIA(India)PrivateLimited

Cell:+91.98.1977.7493,Fax:+91.22.2859.4762

email:[email protected]

DLGAT AND TALTOP RGSTRATON: Rhean D’Souza, AssistantManager

MarketingandProgramDevelopment,DIA(India)PrivateLimited

Tel:+9122.2859.4762,Cell:+9198.2058.7798

email:[email protected]

CANCLLATON POLC: On or before JANAR 15, 2012

CancellationsmustbeinwritingandreceivedbyJanuary15,2012.Registrantswhodonotcancelinwritingbythatdateanddonotattendtheeventwillberesponsibleforthefullregistration

feepaid.Registrantsareresponsibleforcancellingtheirownhotelandairlinereservations.Iftheeventiscancelled,DIAisnotresponsibleforanyairfare,hotelorothercostsincurredby

registrants.

DA reserves the right to alter the venue, if necessary. f an event is cancelled, DA is not responsible for any airfare, hotel or other costs incurred by registrants.

RGSTRATN FS Registration fee includes refreshment breaks, luncheons.

Join DIA now to qualiy to save on uture events and to receive all the benefts o membership.

To see all the benefts o DIA membership, visit www.diahome.org and click on Membership.

Uponcancellation,theadministrativefeethat

willbewithheldfromrefundamountis:

FLL MTNG CANCLLATON(All reunds will be issued in the currency o original payment):

Member/NonmemberRegistration=INR3,000 • StudentRegistration=INR500

ASC RAT SRVC TAX TOTAL

Standad Mmbsip 1768 182 qIr 1950

Stdnt Mmbsip* 725 75 qIr 800

MMR


Indsty 5698 352 q Ir 6050

Acadmia 4285 265 q Ir 4550

Stdnt* 2825 175 q Ir 3000

NONMMR (nclusive of Membership)


Indsty 7466 534 q Ir 8000

Acadmia 6053 447 q Ir 6500

Stdnt* 3550 250 q Ir 3800*

P chck h ppcb cgy:

q Academia q overnment q Industry q CR

q Non-Member q Member : Customer ID No.: _______________

Please Print all information Clearl

Degrees: q Dr. q Mr. q Ms.

Last Name (Family Name)

First Name M.I.

Job Title

Aliation (Company)

Address (Please write your address in the format required for delivery to your country.) q Business Address q Home Address

Postal Code City State Country

Telephone Number Fax Number Mobile Number

email (Required for conrmation) Signatory

Payment contact person’s Full Name Telephone Number Email

*A limited number of student registrations are available. Student Fee does not include membership.Astudentisanundergraduate/graduatewhocandocumentenrollmentinaSignatureaccredited,

degreegranting,academicprogram.Pleasesendcompletedregistrationform,copyofstudentidentication,andpayment.

TOTAL AMONT D: ____________________________

ORGANSATON PAN No.: _________________________

REGISTRATION TERMS AND CONDITIONS: Registration orm should be duly lled, signed by the authorized person.

You are requested to email the duly lled and signed Registration Form rst and then courier/mail

it along with registration ees on or beore 5 working days.

PAyMENT INfORMATION

Completedform,alongwithdraft/chequemadepayabletoDIA(India)

PrivateLimitedshouldbesentto:

RheanD’Souza

DIA(India)PrivateLimited,A-303,WellingtonBusinessPark

Andheri-KurlaRoad,Marol,Andheri(East),Mumbai400059India

Phone:+91.22.6765.3226

Dia Conference Merriot 10-11 Feb 2012

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