Dia Conference Merriot 10-11 Feb 2012
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Transcript of Dia Conference Merriot 10-11 Feb 2012
8/3/2019 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
8/3/2019 Dia Conference Merriot 10-11 Feb 2012
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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
PharmaBusinessExcelIndustriesLimited
DA1| FRDA, FRAR 10, 2011
8/3/2019 Dia Conference Merriot 10-11 Feb 2012
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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
PharmaBusinessExcelIndustriesLimited
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
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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
ASC RAT SRVC TAX TOTAL
Indsty 5698 352 q Ir 6050
Acadmia 4285 265 q Ir 4550
Stdnt* 2825 175 q Ir 3000
NONMMR (nclusive of Membership)
ASC RAT SRVC TAX TOTAL
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