8th Annual Conference...5 8th Annual Conference | 5 9:30-11:00 COnCURREnT SESSIOnS 1A The New...

8th Annual Conference The New Clinical Research Environment in India: Implications and Opportunities

ID# 13659 | October 24-26, 2013

NIMHANS Convention Center | Bangalore, India

Program oVErVIEWThe pharmaceutical industry is at an inflexion with momentous changes staring it in the face. In India too, issues with investment, research, and intellectual property indicate a new environment that has both implications and opportunity. The clinical research environment, in particular, has seen ground-shifting changes. New regulations have made the pursuit of clinical development in India extremely challenging. At the same time, demand for services in the regulation-free domains of remote data processing and IT-enabled offerings is growing at an unprecedented scale. A section of the Indian pharmaceutical industry is at the threshold of entry into uncharted territories with global development of innovative assets and biosimilars, even as it braces for headwinds from a struggling global economy and more demanding regulatory requirements. Scientific advances at the genetic and molecular level and enhanced public and non-profit funding are enabling new approaches to public health concerns.

This conference will provide a forum for academia, industry, regulators and researchers to come together to discuss the new environment for healthcare product development in India – the challenges and the opportunities. Participants will hear about how their peers are coping with new regulations and how they are planning to realize the promise of emerging opportunities.•Program hIghlIghts• Direction, outlook and vision for health related research in India• Review of recent changes in regulations and their implications• Challenges to global development and commercialization ex-India• New opportunities for India-centric global delivery solutions• Global benchmarks in healthcare research regulations• Patient-centric endeavors for awareness and ethics of research

Who shoUlD attENDProfessionals, researchers and clinicians involved in drug discovery and development and regulatory affairs including:

8th Annual ConferenceThe New Clinical Research Environment in India: Implications and Opportunities

ID# 13659 | October 24-26, 2013

NIMHANS Convention Center | Bangalore, India

Program CommIttEE

LarisaNagraSinghVP global Functional resourcing, asIa PaCQuintiles

VivekAhujaDirector - Clinical research & DevelopmentPath

ArunMishrasenior Director, global regulatory affairs, Emerging markets and asia Pacific, gsK

SiddharthShahassociate Director, ls r&D PracticeCognizant

SudhirKandarthsales manager, global Business Unit oracle health sciences

ArshadMohammedDirectorClinical Data management Quintiles

RajeshKherDirector, medical affairs & alliance management (asia Pacific)Biometrics & reportingJanssen research & Development, llC

Helle-MaiGawrylewskisenior Director & headmedical affairs & alliance managementBiometrics & reporting Janssen research & Development, llC

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Andheri-Kurla Road, Marol, Andheri (East) Mumbai 400 059 India

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Worldwide Headquarters800 Enterprise Road, Suite 200

Horsham, PA 19044, USA

PrOgrAm CHAIrs

Shoibal MukherjeeVice President, CMO

(India) & Head Asia Medical

Sciences Group Quintiles

Sairamkumar J.Senior Vice President

& Global Delivery Head, Cognizant Life

Sciences

keynOte sPeAkers

Professor Ranjit Roy Chaudhury Professor Ranjit Roy Chaudhury is National Professor of Pharmacology of the National Academy of Medical Sciences, Chair of the Task Force of the Apollo Hospitals Educational and Research Foundation and a WHO Consultant in the field of Rational Use of Medicines, Traditional Medicine, Research and Regulation of the medical profession. He has been nominated as a Member of the Central Council for Health and Family Welfare in 2009. Professor Roy Chaudhury was responsible for starting the D.M. Course in Clinical Pharmacology in 1978 when he was Professor of Pharmacology and Dean at the Postgraduate Institute of Medical Education and Research, Chandigarh. After retiring from the World Health Organization in 1991 Professor Roy Chaudhury has served as President of the Delhi Society for Promotion of Rational Use of Drugs (DSPRUD) and was the Founder - President of the Delhi Medical Council. He has chaired the Sub-Commission of Macroeconomics and Health and was a member of the Commission set up by the Government of India. He has also chaired the Postgraduate Medical Education Committee set up by the Ministry of Health and Family Welfare. He has been appointed as Advisor to the Dept. of Health and Family Welfare, Govt. of NCT of Delhi and more recently he has been nominated as Chairman of the Expert Committee for Reforms in Drug Regulation and Clinical Trials set up by the MoHFW, Government of NCT of Delhi. He has written twenty five books and has over 225 papers to his credit. He has been bestowed the Honorary Doctor of Science of Chulalongkorn University, Bangkok, the Honorary Fellowship of the Royal College of Physicians of Edinburgh, the Delhi Ki Gaurav award by the Delhi Government and the Padma Shree title by the President of India.

Padmashree Prof. Ranjit Roy Chaudhury

Chairman, Task Force for Research Apollo Hospitals Group

• Drug development and clinical research managers and associates

• Pharmaceutical physicians and medical directors

• Drug safety and drug surveillance personnel• Professionals engaged in discovery research• Clinical pharmacology scientists• Pharmacologists

• Regulatory affairs managers• Regulators• Academic scientists• Biostatisticians• Data managers• Medical writers• Outsourcing and marketing managers• IT professionals

Thank You to Our Media PartnersAll attendees will receive a DIA

Certificate of Attendance.

Anu Acharya CEO

mapmygenome.in

3

8th Annual Conference | 3

The New Clinical Research Environment in India – Implications & Opportunities

DAY 2 | FRIDAY, OCTOBER 25, 2013

ClInICAl TRACk 1

AudITORIuM 1

ClInICAl TRACk 2

AudITORIuM 1

IT TRACk

AudITORIuM 2

MEDICAl WRITInG/ BIOSTATISTICS

DIA-AIMWA SESSIOn

LEVEL 1 HALL 1

The new Clinical Research Environment

Global Development of Biosimilars

Discovery, Pre-Clinical, Early Development,

Phase 1, BA / BE, labslean Medical Writing

Building the Framework - WIP

Patient Awareness, Advocacy and Informed

Consent

IT in Clinical Records and Collaboration

Interactive Workshop on lean Writing

Evolving Pharmaceutical Regulations in the Region

India as an Innovation & Delivery Hub

Risk-based Monitoring Quality Documents:

From Beginning to End

AudITORIuM 1 COMMOn SESSIOn - Media, Activism and Judicial Intervention in Clinical Research

DAY 3 | SATURDAY, OCTOBER 26, 2013

ClInICAl TRACk 1

AudITORIuM 1

ClInICAl TRACk 2

AudITORIuM 3

IT TRACk

AudITORIuM 2

MEDICAl WRITInG/ BIOSTATISTICS

DIA-AIMWA SESSIOn

LEVEL 1 HALL 1

Recent Developments in Clinical Trials Data Sharing

Compensation for Injuries to Participants in Research:

A Trans-national Perspective

Manufacturing, Supply Chain, Regulatory, Safety

and Risk Management

Medical Writing Competency Building

DIA-FERCI SESSIOn: Ethics Committee: Coping with Regulatory Changes

Risk-based Approach to Monitoring CR

Sales & Marketing; Analytics

The new Clinical Research Environment in India: Implications

& Opportunities in Biostatistics and Statistical Programming

Industry-Regulator Interactions – Global

Clinical Review Practices

Managing the Workforce – The Competition for Talent

SMAC (Social Media, Mobility, Analytics

and Cloud) or newer Technologies

Open Discussion Forum: How Can We

Take the Medical Writing Profession to

the next level in India?AudITORIuM 1

Panel Discussion

Closing

At-A-Glance Session Schedule

DAY 1 | THURSDAY, OCTOBER 24, 2013 | AUDITORUM 1

Vaccine Development – A Challenge like no Other

Health Outcomes and Policies for the Developing World

4

4 | 8th Annual Conference

10:15-10:45 OPEnInG CEREMOnY & ExHIBITIOn OPEnInG

10:45-11:15 GUEST OF HOnOR

AltafLal(Invited)Country Director US FDA India Office

M.MadanGopalIAS, Principal Secretary to Govt. of Karnataka Health and Family Welfare Department

M.K.BhanFormer Secretary, Department of Biotechnology (DBT) Government of India

B.R.JagashettyDrugs Controller, Karnataka State

11:15-11:45 kEYnOTE 1

PadmashreeProf.RanjitRoyChaudhuryChairman, Task Force for ResearchApollo Hospitals Group

11:45-12:15 kEYnOTE 2

AnuAcharyaCEO mapmygenome.in

12:15-13:30 lUnCH & ExHIBIT VISIT

13:30-15:00 Vaccine development – A Challenge Like No Other SeSSion Chair M.K.BhanFormer Secretary, Department of Biotechnology (DBT) Government of India

Approximately 15% of the disease burden in India, and most childhood deaths, are potentially vaccine preventable. Speakers in this session will address the imperatives for India in vaccine development, summarize the collaborative efforts across academia, industry, government and philanthropic organizations, speak about the unique challenges of vaccine development, and examine the risks and benefits to patients participating in vaccine trials.

Disease Burden and the Imperatives for Vaccine Development in IndiaGagandeepKangProfessor of MicrobiologyHead, The Wellcome Trust Research Laboratory Department of Gastrointestinal SciencesCMC, Vellore

Unique Challenges in Vaccine DevelopmentRajatGoyalCountry DirectorIAVIIndia

Myths and Realities – How Patients Benefit from Vaccine TrialsTemsunaroRongsenChandolaCentre for Health Research & DevelopmentSociety for Applied Studies

15:00-15:30 TEA/COFFEE BREAk

15:30-17:30 Health Outcomes and Policies for the developing WorldModerator

RajShankarGhoshInterim Deputy DirectorVaccines Delivery, India, Bill and Melinda Gates Foundation

new Vaccines Adoption in Universal Immunization ProgramsTBD

Health and Demographic Surveillance Systems (HDSS) – A Platform for Public Health ResearchAshishBavdekarConsultant in Pediatric Research Department of Pediatrics &Vadu HDSS, Vadu Rural Health Program KEM Hospital Research Centre, Pune, India

Innovation in Technology: Benefits in Public Health TarunVijCountry Program Leader, PATH

Panel Discussion: Health Outcomes and Policies for the Developing WorldHarishIyerCEO, Shantha Biotech TarunVijCountry Program Leader, PATHAshishBavdekarConsultant in Pediatric Research Department of Pediatrics &Vadu HDSS, Vadu Rural Health Program KEM Hospital Research Centre, Pune, India

DAY 1 | THURSDAY, OCTOBER 24, 2013

IN-COMPANY TRAINING SOLUTIONS

DIA is recognized throughout the life sciences community as the definitive source for information

about the discovery, development, and life cycle management of pharmaceuticals, biotechnology,

and medical products.

Contact [email protected] or go to www.diahome.org/incompany and

submit a consultation request.

5


9:30-11:00 COnCURREnT SESSIOnS

1A The New Clinical ResearchEnvironment 1B Global development of

Biosimilars 1C discovery, Pre-Clinical, Earlydevelopment, Phase 1,

BA/BE, Labs

In this session the speakers will review the clinical research environment and the recent changes that are transforming the conduct of clinical trials in India. The impact of these changes on patient protection, clinical trial quality, attractiveness as a destination, and clinical research volume will be analyzed.

India has emerged as a hot bed for the development of biosimilars. Speakers in this session will review the progress made by Indian companies in pursuing the biosimilars opportunity, their challenges, and the lessons that can be learned from studying how key regulatory agencies across the world have dealt with biosimilars development proposals.

Discover, how technology is enabling better business outcomes in the areas of Discovery, Pre-Clinical and early clinical development. Hear from Business Users of the technology on how better effectiveness has been achieved, versus better efficiency/product of the older technologies.

The new Clinical Research Environment AnilSethDirector Clinical ResearchEli Lilly

Implications, Impact and OutcomeMubarakNaqviSenior Director, Clinical Study UnitSanofi Synthélabo

Direction and Outlook SureshRamuCo-Founder and CEOCytespace Research

Global View on Biosimilar Development StrategyAndrewRankinVice President, BiopharmacueticalsPrescient Healthcare Group

India and the Biosimilars Opportunity ArvindRaghunathDirector Prescient Healthcare Group

Program Design Challenges and Case Studies CharuManaktalaMedical Director, BiosimilarsQuintiles

The Cloud Based IT Architecture - Example / Case StudyParthaChakrabortySenior Director, Head Global Delivery for Life Sciences R&D Practice, Cognizant, India

Drug Discovery and lead OptimisationK.K.BhagchandaniDirector of Business Strategy & Sales (Asia Pacific), Advanced Chemistry Development, Inc. , (ACD/Labs)

Crowd Sourcing in Drug Development - Will it work?ZakirThomasProgram DirectorOpen Source Drug Discovery Initiative (OSDD)



2A Building the Framework – WIP 2B Patient Awareness,Advocacy

and Informed Consent 2C IT in Clinical Records andCollaboration

This session will review the work and philosophy behind the key elements of the new site accreditation system being introduced in India, the working of the compensation system that has been the topic of much policy deliberation in recent years, and the revamped regulatory apparatus expected to monitor the new system.

This session will focus on the patient in clinical trials. Speakers will discuss patient advocacy and approaches towards increasing awareness of clinical trials among the patient population. Means for enhancement of the informed consent process will be explored, including ways to improve the comprehensibility of the informed consent document, suggestions for audiovisual documentation of the consenting process, and means for assessment of comprehension of informed consent.

Probably the most happening place for innovation, investment and industrialization of technology in pharma value chain is clinical development. This session will exploit how new technological developments is taking the clinical development into next horizon, be it newer model for Trial Master File or Investigator collaboration or advances in technology for medical writing.

Redesigning Informed ConsentMadelineDucateExecutive Vice President, Global Operations Pharm-Olam International Ltd

Site Accreditation FrameworkShoibalMukherjeeVice President, CMO (India) & Head Asia Medical Sciences Group Quintiles

Enhancing Clinical Research Capability in IndiaVivekAhujaDirector, Clinical Research & Development, PATH

Patient Awareness Program Support and AdvocacyDurhaneWong-RiegerChair International Alliance of Patients’Organization (IAPO)

Enhancing Informed ConsentRonaldHeslegraveChief of Research, William Osler Health System Toronto, Ontario, Canada

Update on PARTAkE (Public Awareness of Research for Therapeutic Advancements through knowledge and Empowerment)NandiniKumarFormer Deputy Director General Sr. Grade (ICMR), Adjunct Visiting Professor Kasturba Medical College, Manipal

Why Technology at Site is Important for Risk-based MonitoringLalitPaiPharma Research Entrepreneur Cytespace Research

Big Data in Drug DevelopmentSudeepPatnaikVice President, IT Quintiles

Data Integration and Analytics in Clinical DevelopmentSubbarajuSagiManaging Director, TechSol India

13:00-14:00 nETWORkInG lUnCH


6




3A Evolving Pharmaceutical Regulations in the Region 3B India as an Innovation and

delivery Hub 3C Risk-based Monitoring

With the end of the war in Sri Lanka, and the rise of economic activity, there is cautious interest among Sri Lankan healthcare professionals and authorities for the country to participate in global clinical research, and new policy initiatives are on the anvil. In India too, a bill containing major revisions to the Drugs and Cosmetics Act has been introduced in parliament. This session will review the evolution of clinical research environment and regulations in Sri Lanka, and take a closer look at the changes likely to be introduced through upcoming amendments to the law in India.

More than 15 years since sections of the Indian pharmaceutical industry began to invest in drug discovery research, we have yet to see the first successful global commercialization of a product discovered in India. What are the challenges? Are we on the threshold now? What about global delivery opportunities in the clinical space? Speakers in this session will address these questions and share some of their success stories.

Risk-based monitoring is the most talked about concept in the entire value chain. Hear from industry and technology thought leaders on the actual benefits it brings to the table.

Clinical Research Environment and Regulations in Sri lankaAsitadeSilvaHead, Clinical Trials Unit, University of KelaniyaSri Lanka

Drug and Cosmetics Amendment Bill 2013AlishanNaqveePartner, LexCounsel Law Offices, New Delhi

The Bill: A Critical AnalysisShoibalMukherjeeVP & Head Asia Medical Sciences Group, Quintiles

Drug Discovery – How is India doing?J.B.GuptaSenior Vice President, GVK Biosciences

Remote Clinical Operations – Opportunities and ChallengesHemantRehaniVice President and Head, CDS, Quintiles India

The World of Bio SignalsArjunKalyanpurManaging DirectorTeleradiology Solutions

Success Story of RBM for a leading Biotech SponsorJagadeeshRudraswamymathDirector CDM, Global Data and Safety Monitoring, Quintiles

RBM - Significant Cost Savings along with Effective and Efficient MonitoringRajeshJainDirector, Operations Cognizant Business Process Services

IT Solution Framework for Enabling RBMT.RaghuBabuDeputy General Manager, OperationsHCL Technologies Ltd.


16:00-17:00 COMMOn SESSIOn

4 Plenary Session: Media, Activism and Judicial Intervention in Clinical Research

This panel discussion will call upon prominent journalists, legal personalities, and passionate clinical researchers to engage in a session of constructive conversation regarding the role activists and the media have played in shaping the clinical research environment and the role the country requires these parties to play in the future.

Moderator AnilSethDirector Clinical ResearchEli Lilly

PaneliStS

AlishanNaqveePartner Lexcounsel DurhaneWong-RiegerChair International Alliance of Patients’ Organization (IAPO) PoonamBagaiFounder Chairman Cankids...KidsCanSanjayPaiConsultant Pathologist Pathology and Laboratory HeadMedicine Columbia Asia Referral Hospital

HariPulakkatSenior Editor, Economic TimesSeemaSinghSenior Editor, Forbes India

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5AB1Recent developments inClinical Trials data Sharing 5AB2 5C Manufacturing, Supply Chain,

Regulatory, Safety and Risk Management

This session will trace the background and discuss the latest developments in regard to proposals that participant-level clinical trials data be widely shared with secondary researchers. Some industry sponsors of research (GSK, Roche) and industry trade associations (PhRMA, EFPIA) have issued their own voluntary guidelines and principles for sharing these data, while government agencies – primarily the European Medicines Agency (EMA) but also the FDA – have proposed requirements that sponsors share data. The session will explore the rationales off ered for these proposals and the risks to privacy and commercial interests, and will analyze the EMA proposals, which are to be fi nalized in November 2013. The session will feature the new practices and principles of one industry sponsor (GSK) in this area.

Participation in clinical trials carries risk of injury, which can be caused by poor design of a study by an industry sponsor or academic institution, poor conduct of a trial by researchers, poor clinical care that is required by clinical trial protocol but that is delivered by non-researcher physicians, and failure of research participants to follow study protocol. There has been much international debate, and national debate, as within India, about appropriate standards for when compensation should be awarded, how to calculate that compensation, when warranted, and who should be responsible for compensation. This session will seek to advance the discussions within India by putting these issues in a trans-national context, relating experiences from other jurisdictions, specialty societies, and research ethics groups.

With ever-changing regulations and the pressure for an effi cient supply chain, various pharma companies are experimenting with a variety of strategies to reduce cost and ensure compliance. Technology vendors are often taking the lead in assisting pharma companies to be prepared for the dynamic environment. This session will discuss such proven strategies and probable models of innovation.

MarkBarnesMulti-Regional Clinical Trials Center at Harvard (MRCT) and Ropes & Gray LLPArunMishraSenior Director, Global Regulatory Aff airsEmerging Markets and Asia Pacifi c, GSK

SeSSion Chair

MarkBarnesMulti-Regional Clinical Trials Center at Harvard (MRCT) and Ropes & Gray LLP

Each speaker will present on the compensation of injuries to research participants from the point of view of their own organizations:UrmilaThatteDirector, FERCI, Prof. and HeadDepartment of Clinical PharmacologyKEM Hospital, MumbaiSuneelaThattePresidentIndian Society of Clinical ResearchISCR

Challenges in Clinical Trial Supply ManagementVerender KumarSenior Director PAREXEL

Impact of new EU Pharmacovigilance legislations on the IndustrySanjeevMiglaniHead, Pharmacovigilance US OperationsAPCER Pharma

Role of Technology in Meeting Dynamic Regulatory EnvironmentRajeshwariBijurAssociate Director, Process Center, Global Data and Safety Monitoring, Quintiles



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Compensation for Injuries to Participants in Research: A Trans-National Perspective

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6A 6B Risk-based Approach toMonitoring CR 6C

Sales and Marketing; Analytics

Ethics committees are the keystone of research ethics. This session will review the registration requirements introduced earlier in the year. The proposed accreditation requirements for ethics committees will be discussed, and the audience will get a peek at how ethics committees are managing to cope with the new systems.

Clinical and Regulatory experts will outline steps to consider during protocol development and share their insights to enhance risk based monitoring initiatives. They will discuss examples of how a well-designed protocol can prevent errors in collection of data and enhance the reliability of the study.

This session will exploit the new, proven models and trends in sales and marketing (backed by technology) for better commercial success, including competitive positioning.

EC PerspectivesUrmilaThatteDirector, FERCI, Prof. and Head,Department of Clinical PharmacologyKEM Hospital, Mumbai

Sponsor PerspectiveVirajSuvarnaMedical Director Boehringer Ingelheim

Investigator PerspectiveSanjayPaiConsultant Pathologist, Pathology and Laboratory Head, Medicine Columbia Asia Referral Hospital

Way to Accreditation of IECNandiniKumarFormer Deputy Director General Sr. Grade (ICMR), Adjunct Visiting Professor Kasturba Medical College, Manipal

SunitaZalaniVice President, Global Regulatory Affairs Onyx Pharmaceuticals• Overview of FDA guidance on risk-based

approach to monitoring• Overview of EMA Reflection paper on risk-

based quality management in clinical trials• Importance of a well-designed protocol in

managing risksChiragTrivediDeputy Director, Project Management & Strategic Initiatives, Sanofi India• How companies are implementing risk-based

monitoring strategies • Roles and responsibilities of the CRAs and study

personnel • Pros and cons of traditional versus new

approach for monitoring clinical trials

Analytics Driven Brand ManagementTBD

The Future of Selling - Impact of Social Media, Digital and Analytics for PharmaAnupSoans(TBC)Editor, MedicinMan

leveraging Competitive Intelligence for Development and CommercializationRajeshKuppuswamySenior Director - Consulting - Life Sciences Cognizant Technology Solutions

13:00-14:00 nETWORkInG lUnCH & ExHIBITIOn VISIT


dIA-FERCI SESSION: Ethics Committee: Coping with Regulatory Changes

Instant Education in Your Own Place at Your Own Pace.As the world’s largest professional association for all professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, and medical products, DIA is recognized around the world as the definitive source for information about clinical research, clinical safety, good manufacturing practices, regulatory affairs, medical communications, and more. DIA’s eLearning program delivers current, relevant, and effective education and professional training—anywhere, anytime.

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• Medical Devices• Regulatory Affairs• Validation and Part 11 Compliance

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7A Industry-Regulator Interactions –Global Clinical Review Practices 7B Managing the Workforce –

The Competition for Talent 7C SMAC (Social Media, Mobility,Analytics and Cloud) or

Newer TechnologiesThis session will focus on examples of robust industry regulator interactions during the regulatory review process in key developing and developed countries across the globe. Speakers will demonstrate how collaboration makes for greater effectiveness and efficiency of the review process and aids improved decision-making.

As the size of organizations grow and competition for talent in the life sciences becomes more acute, attracting and retaining the best talent is key to managing growth. Speakers with experience in the domain will discuss issues of workforce management in clinical research, from techniques in recruitment to retention, engagement and talent management.

There are many new technologies in the pharmaceutical industry, including Social Media, Mobility, Analytics, Cloud, etc. Are they hype or reality? Is the pharma industry ready for such technology? What are the proven case studies of its benefits? Hear from industry and technology thought leaders on the value of new technology and approaches to adopt it.

SeSSion Chair

ArunMishraSenior Director, Global Regulatory Affairs, Emerging Markets and Asia Pacific, GSK

Elements of an Effective and Efficient Review Process – Examples from key Emerging Markets, EU, US and SwitzerlandChetEliasDirector, GRAAS JAPAC, Amgen, US

Engaging Regulatory Authorities During Complex Drug Development – Scientific Advice Process in Emerging MarketsArunMishraSenior Director, Global Regulatory Affairs, Emerging Markets and Asia Pacific, GSK

Sound Clinical Reviews/Mind Over Matter - Any Role for the HeartAamirShaikhFounder, ASSANSA, India

People Management in High Performing OrganizationsSeSSion Chair

SabitaRebeccaPartner, Leader Prospects India Pvt. Ltd.Bangalore, India

Recruitment (Strategy of Ramping Up) Down-sizing and ManagementSureshSharmaAssociate Vice-President TATA Consultancy Services New Jersey, USA

Employee Retention and EngagementKrathishBopannaPresident & CEOSemler Research CenterBangalore, India

Career Path and DevelopmentAnandEswaraiahHead of Clinical Development and Regulatory Affairs, Clinigene International LimitedBangalore, India

Mobility - A Case for IT Based Better Efficiency, Cost Saving and Effective Collaboration EdselPerieraCIO, Glenmark, India

Improving Pipelines - Impact of IT Initiatives

Social Media, Digital and Analytics for PharmaDineshChindarkarCo-Founder & Vice President - Operations MediaMedic Communications

Sowmyanarayan Srinivasan Director, Life Sciences R&D Practice, Cognizant


16:00-17:30

8 Panel discussion and Closing

The new Clinical Research Environment in India: Implications and OpportunitiesModerator

ShoibalMukherjeeVice President, CMO (India) & Head Asia Medical Sciences GroupQuintilesPaneliSt

InvitedSpeakers


10


DAY 2 | FRIDAY, OCTOBER 25, 2013 CONCuRRENT WITH A, B ANd C TRACK SESSIONS

9:30-11:00 Lean Medical Writing: Practical Applications for Authoring Clinical Study Reports SeSSion ChairS

PaulSokolSenior Director, Neuroscience, Biometrics & ReportingJanssen Research & Development, LLC

Helle-MaiGawrylewskiSenior Director & Head, Medical Affairs & Alliance ManagementBiometrics & Reporting, Janssen Research & Development, LLC

Lean PrinciplesPaulSokolSenior Director, Neuroscience, Biometrics & ReportingJanssen Research & Development, LLCApplications of Lean Principles in devising Medical Writing StrategiesNeeraShettyDeputy General ManagerCognizant Technology SolutionsImplementing Lean CSR Principles: A Medical Writer’s PerspectiveAmbikaSubramanianLead Medical Writer & Project Coordinator, Scientific Writing & Regulatory Affairs, Sciformix Technologies Private LimitedQuestions and Open discussion – Take Away PointsHelle-MaiGawrylewskiSenior Director & Head, Medical Affairs & Alliance ManagementBiometrics & Reporting, Janssen Research & Development, LLC


11:30-13:00 Interactive Workshop on Lean Writing FaCilitator


Example demographic, safety, and other data for construction of report sections, followed by exercises


14:00-15:30 Quality documents: From Beginning to End

SeSSion ChairS


RoopaBasrurDirector, Medical Writing Services India, PAREXEL International

SPIRIT: Initiative to Improve Clinical Trial Protocols Introduction and ReferencesHelle-MaiGawrylewskiSenior Director & Head, Medical Affairs & Alliance ManagementBiometrics & Reporting, Janssen Research & Development, LLCEffective Project Management is Necessary to Produce High Quality documentsGarimaPallaviManager, Medical Writing Services India, PAREXEL InternationalRobust document Reviews – Quality and Peer ReviewAnupamaRamkumarDirector, Arkus Clinical Trial Support Solutions

DAY 3 | SATURDAY, OCTOBER 26, 2013 CONCuRRENT WITH A, B ANd C TRACK SESSIONS

9:30-11:00 Medical Writing Competency BuildingSeSSion ChairS

VatsalShahVice President & Global Head, Medical Writing & Pharmacovigilance SIRO Clinpharm

RajeshKherDirector, Medical Affairs & Alliance Management (Asia Pacific)Biometrics & Reporting, Janssen Research & Development, LLC

CARE – An Interactive Program for Enhancement of Skill Sets for Medical WritersSeemaGurbaniSenior Manager, Life Sciences, TATA Consultancy ServicesRajeshKherDirector, Medical Affairs & Alliance Management (Asia Pacific) Biometrics & Reporting, Janssen Research & Development, LLCdeveloping Skills for Robust document Reviews - Quality and Peer ReviewBinduNarangDirector, Scientific Writing and Regulatory AffairsSciformix Technologies Private LimitedEffective Mentoring and Coaching in Medical Writing VatsalShahVice President & Global Head, Medical Writing & Pharmacovigilance SIRO Clinpharm


11:30-13:00 The New Clinical Research Environment in India: Implications & Opportunities in Biostatistics and Statistical Programming

SeSSion ChairS

ArghyaChattopadhyayVice President, Biostatistics & Programming TATA Consultancy Services

ReshmaChowdhryDomain Consultant, Biostatistics & Programming TATA Consultancy Services

Beyond Tables, Listings and FiguresNithiyanandhanAnanthakrishnanSenior Manager, SAS Programming, ICON Clinical ResearchA Brief Review of Phase 1 and Clinical Pharmacology Statistics in Clinical drug developmentNandKishoreRawatLead Statistician, Cytel Statistical Software & Services Pvt. Ltd.Biostatistics and Programming – Outsourcing Landscape Opportunities and ChallengesTusharSakpalDomain Consultant, Biostatistics & Programming TATA Consultancy ServicesNew Clinical Research Environment in IndiaTommyPedersenHead, Biostatistics, Quintiles


MEDICAl WRITInG/BIOSTATISTICS - DIA-AIMWA SESSIOn

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DAY 3 | SATURDAY, OCTOBER 26, 2013 continued

14:00-15:00 Open discussion Forum: How Can We Take the Medical Writing Profession to the Next Level in India?Moderator

RadhikaBobbaRegional Director, India and Far East PSI CROPaneliStS

VatsalShahVice President & Global Head, Medical Writing & Pharmacovigilance SIRO Clinpharm

BinduNarangDirector, Scientific Writing and Regulatory AffairsSciformix Technologies Private Limited



RoopaBasrurDirector, Medical Writing Services India, PAREXEL International

PoojaPhogatSenior Manager, Medical Writing & Medical Information Kinapse Ltd.

SheetalS.IngoleSenior Manager, Medical Affairs & Pharmacovigilance Ecron Acunova

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NameoftheHotel Dist.fromNIMHANS

ContactDetails RateINRSingleRoom

RateINRDoubleRoom

Inclusions

President Hotel

Diagonal Road, 3rd Block, Jayanagar Bangalore - 560 011

3- 4kms

Approx. 20 -25 mins travel time to NIMHANS

NASIM 91 - 80 - 41808777/ 9945454541

Email : [email protected]

Comfort – 4232.00

Luxury – 6030.00

Comfort – 4761.00

Luxury – 6559.00

Taxes Gym Facility Business Center Special Low Calorie Breakfast Counter Buffet Breakfast Check-in & check out time is 24 Hrs. Airport Pick-up & Drop on chargeable basis @ 1600 + taxes ( one way ) Nimhans Pick-up & Drop on chargeable basis @ 450 + taxes ( one way )

davanam Sarovar Portico

Davanam Plaza Opp. Madiwala Police Station Hosur Main Road, Bangalore-50068

3-4 kms


Margaret 080-41153344/ 5588/5599/ +919900063608

Email: [email protected]

4000+tax 5000+tax Breakfast Wifi Complimentary both ways office transfers to Nimhans on sharing basis

Pride Hotel

93, Richmond Road, Bangalore -560 025

4-5 kms


Amla Dsouza (080) 43484348

Email: [email protected]

Deluxe 4000 + tax

Superior 5000 + tax

Deluxe 4500 + tax

Superior 5500 + tax

Buffet breakfast Complimentary Tea / Coffee maker in all rooms Complimentary one bottle of Mineral water Airport transfers on chargeable basis: Pickup Rs 1411/- & drop Rs 1341/- by Ford Ikon vehicle Wi-Fi Charges: 1 Hour :Rs.386 Plus 19.42% Tax 24 Hours : Rs.773 Plus 19.42% Tax Transport to NIMHANS on chargeable basis

IBIS Hotel

Bengaluru Techpark, Opposite RMZ Ecospace Business Park, Marthahalli – Sarjapur Outer Ring Road, Bengaluru – 560103,

3-4 kms


Sachin Kumar Raghav +91 (80) 66700600 Mobile: +91 9538897310


3200 +Taxes

- Buffet Breakfast at pre decided venue per night of stay Complimentary internet access (at base speed) Complimentary Transfers by shared cars to NIMHANS Convention Centre Complimentary Access to ibis Gymnasium Use of Ironing Corner located on each floor Use of ice and water vending Machine located on each floor 15 minutes complimentary internet usage at Dell corner Hotspot free Wi-Fi at The Hub Additional in room inclusions In room Tea and coffee making facilities Housekeeping service Mini Fridge Electronic Safe 10% discount on Buffet Dinner at Spice-It restaurant which is currently priced at INR 599+Taxes

Novotel Hotel

Bengaluru Techpark, Opposite RMZ Ecospace Business Park, Marthahalli – Sarjapur Outer Ring Road, Bengaluru – 560103,

3-4 kms


Sachin Kumar Raghav +91 (80) 66700600 Mobile: +91 9538897310


6000 +Taxes

- Buffet Breakfast at pre decided venue per night of stay Complimentary Wi-Fi internet connectivity(At base speed) Transfers by shared cars to NIMHANS Convention Centre Access to In-Balance fitness studio and Swimming pool at Novotel 20 minutes complimentary internet usage at Mac corner Note: 20% discount on Buffet Dinner at The Square restaurant which is currently priced at INR 1099+Taxes

Best Western Premier La Marvella

#1, 14th Cross, South End Circle, 2nd Block Jayanagar, Bengaluru 560011.

3-4 kms


Lohith Bopanna +91 80 4333 5333 Cell : +91 9663 887 887

E-Mail: [email protected]

5,250 incl of taxes

6,250 incl of taxes

Breakfast Complimentary Pick up and drop to NIMHANS Convention center Complimentary usage of Internet through Broadband / Wi-Fi. Complimentary usage of Gymnasium Complimentary usage of Swimming Pool, Steam & Sauna

To avail special negotiated rates, please mention your participation in the dIA Conference at the time of booking.

HOTEl InFORMATIOn

PLEASE CONSIdER THIS FORM AS AN INVOICE

8th Annual Conference Meeting I.d. # 13659 | October 24-26, 2013 | NIMHANS Convention Center | Bangalore, India

TRAVEL INFORMATIONAttendees should make airline reservations as early as possible to ensure availability. Nearest Airport: Rajiv Gandhi International Airport, Bangalore.

VENuE : nIMHAnS Convention Center | Bangalore, India 1st Main Road,Someshwaranagar, Hombegowda Nagar, Bangalore, Karnataka, 560029

HOTEL RATES: To avail special negotiated rates, please mention your participation in the DIA Conference at the time of booking.

MEETING ANd REGISTRATION CONTACTMEETING MANAGER: Manoj Trivedi, Senior Manager Marketing and Program Development, DIA (India) Private Limited Cell: +91.98.1977.7493, Tel: +91.22.6765.3226 email: [email protected]

Drug Information Association A-303, Wellington Business Park 1 | Andheri-Kurla Road, Marol Andheri East, Mumbai 400059

CANCELLATION POLICY: On or before OCTOBER 10, 2013Cancellations must be in writing and received by October 10, 2013. Registrants who do not cancel in writing by that date and do not attend the event will be responsible for 75% of the registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations.

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

FuLL MEETING CANCELLATION (All refunds will be issued in the currency of original payment).

Each and every attendee will get Complimentary DIA MEMBERSHIP.

REGISTRATIoNFEESRegistration fee includes refreshment breaks, and will be accepted by mail/courier.

Join DIA now to qualify to save on future events and to receive all the benefits of membership. To see all the benefits of DIA membership, visit www.diahome.org and click on Membership.

*A limited number of student registrations are available.

A student is an undergraduate/graduate who can document enrollment in a Signature accredited, degree granting, academic program. Please send completed registration form, copy of student identification, and payment.

REGISTRATION TERMS AND CONDITIONS: registration form should be duly filled, signed by the authorized person. You are requested to email the duly filled and signed registration Form first and then courier/mail

it along with registration fees on or before 15 working days before the event.

Please check the applicable category:

q academia q government q Industry q student

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

Please Print all information Clearly

Degrees: q Dr. q Mr. q Ms.

Last Name (Family Name)

First Name M.I.

Job Title

Affiliation (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 confirmation) Signatory

Payment contact person’s Full Name Telephone Number Email

Total Amount Due Organisation PAN no.

PAyMENT INfORMATIONCompleted form, along with draft/cheque made payable to DIA (India)

Private Limited should be sent to:

Bhavesh Vora

Senior Executive Accounts, DIA (India) Private Limited Cell: +91.982.097.2630, Tel: +91.22.6523.0676 email: [email protected]

register 10 from your company and receive the 11th free! Contact our group discount representative for details or call +91.98.2058.7798

EARLY BIRd (BEFORE SEPTEMBER 30, 2013) AFTER SEPTEMBER 30, 2013 BASIC RATE (INR) SERVICE TAx

12.36%TOTAL (INR) BASIC RATE (INR) SERVICE TAx

12.36%TOTAL (INR)

Industry-AIMWA Members 9000 1113 10113 10000 1236 11236Industry (Non Members) 11000 1360 12360 12000 1483 13483Academia 5000 618 5618 6000 742 6742Students 3500 433 3933 4000 495 4495

50tH AnnUAL meetIngCelebrate the Past - Invent the Future June 15-19, 2014 | san Diego, CA | san Diego Convention Center

DIA 2014SAVETHE

dATE

For more information, visit diahome.org/DIA2014

8th Annual Conference...5 8th Annual Conference | 5 9:30-11:00 COnCURREnT SESSIOnS 1A The New...

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