Optimizing the Use of Data Standards 18th February … SDE Delhi Brochure WEB .pdfOptimizing the Use...

Delhi 2017 | PhUSE Single Day Event | 1

DelhiSingle Day Event

Optimizing the Use of Data Standards18th February 2017Crown Plaza, New Delhi

2 | PhUSE Single Day Event | Delhi 2017 Delhi 2017 | PhUSE Single Day Event | 3

Dear Single Day Event Attendees,

It is our great pleasure to welcome you to this event.

Today’s Single Day Event (SDE) is focused on ‘Optimizing the Use of Data

Standards’. Currently within the industry, the development and adoption

of data standards over the last decade has shown significant promise in

improving efficient delivery of data to support drug product and device

submissions as well as the review process. However, there have also been

gaps, issues and challenges in the interpretation and use of data standards.

This SDE will serve as a great platform for all stakeholders to share, discuss

and enhance their knowledge, understanding and application of data

standards in their day-to-day journey of analysis. It will be a great stage for

collaborative discussion on the various topics of the day.

A big thanks to our sponsors, Chiltern, doLoop Technologies, GCE Solutions,

MMS Holdings and PPD, for their generous support of this SDE. Additional

thanks to the Organizing Committee, who have contributed greatly to the

successful preparation and management of the event.

Our presenters are the cornerstones of the event, and we are grateful

for the time and effort they have dedicated in choosing interesting and

relevant topics and providing enjoyable presentations. The majority of the

presentations are ‘never seen before’, demonstrating the enthusiasm of our

community in ensuring you receive new information.

Many thanks for your participation. Looking forward to a great day!

Best regards,

Pam Howard, Sunil Bhatia and Sarvesh Singh

PhUSE Asia Single Day Event Organizing Committee

Introduction

Welcome to Delhi

Sarvesh SinghPhUSE Asia Director

Pam HowardICON

Sunil BhatiaTCS

Your guide to the day

AgendaTime Title and Speaker

08:30–09:00 Welcome refreshments

09:00–09:15 Welcome Note

Sunil Bhatia, TCS, SDE Co-Chair

09:15–09:45 Welcome & Overview of PhUSE

Sarvesh Singh, PhUSE Asia Director

09:45–10:15 Keynote

Pam Howard, ICON, SDE Co-Chair

10:15–10:45 Data Analysis of Sources of Finance and Treatment with Regard to Medical Advice

Mukesh, Government of India

10:45–11:15 Data Standards in Clinical Research: Present Scenario,

Challenges and Future Directions

Mayank Anand, INC Research

11:15–11:30 Morning break

11:30–12:00 Use TA Guidelines to Optimize Your Standardization Efforts

Neha Srivastava & Gaurab Chakraborty, Chiltern

12:00–12:30 CDISC SDTM Standards Implementation –

Common Challenges and Best Practices

Shrishaila Patil, PPD

12:30–13:00 SDTM Submission Package: What Lies Beneath?

Puja Kawle, Cytel

13:00–14:00 Lunch and networking

14:00–14:30 Clinical Trials and SDTM Standards

Prasanna Parthasarathy & Debasis Sahu, ICON

14:30–15:00 ADaM: Where Do I Start?

Krupali Ladani & Sangram Parbhane, doLoop Technologies

15:00–15:30 SEND: A New Avenue for Data Standards

Arnab Goswami, QuintilesIMS

15:30–16:00 Challenges in Optimizing the Use of Data Standards

Jyotirmay Shukla, TCS

16:00–16:15 Afternoon Break and PhUSE 100th SDE Celebration

16:15–17:45 Panel Discussion Q&A

Pam Howard, Sunil Bhatia, Avinash Kumar & Mayank Anand

17:45–18:00 Wrap-up & Closing Remarks

Sarvesh Singh, PhUSE Asia Director


Speakers and abstractsYour guide to the day

Pam Howard, ICON, SDE Co-ChairSarvesh Singh, PhUSE Asia Director & Sunil Bhatia, TCS

Abstract

The impetus for data standards is clear: standards provide

a common language and set of expectations that enable

interoperability between systems and/or devices. Standards

are documented agreements on representation, format, and

definition for common data. And in terms of clinical trials,

standards are a requirement of the regulatory authorities, which

provides a very strong impetus for implementation! But has

standardization to date delivered what we have expected? Has

the return on investment been delivered? Have we lost efficiency

and/or knowledge by implementing standards? Is the cost of

implementing standards underestimated?

Biography

Pamela Howard currently holds the position of Head and

Global Vice President of ICON’s Biostatistics & Programming

department. Pam is a strategic executive with 20+ years of varied

operational experience in clinical, biostatistics, programming

and data management functions, working in the pharmaceutical/

CRO industry. With a proven record of consistent high

performance, delivery of global business & financial objectives

and managing complexity in both line management and project

management roles, Pam is highly driven to innovate to improve

organizational efficiency whilst maintaining overall quality. She

has recently completed the University College Dublin Certificate

in International Business Management (2014), Lean Six Sigma

(2014) & the Chartered Directors program with the Institute of

Directors (2016).

Biographies

Sarvesh Singh is Vice President, Data Management at ICON

Clinical Research. He is also on the PhUSE Board, responsible

for PhUSE operations in Asia (India, China and Japan).

Apart from India, Sarvesh has also lived and worked in the USA

and the Netherlands for close to five years. He completed his

MBA from the Rotterdam School of Management (Netherlands)

and his MSc in Statistics from the University of Delhi. Prior to

joining ICON, he worked with Tata Consultancy Services for

close to 10 years, managing a part of their operations for Eli

Lilly in the USA and Astellas in the Netherlands. He has also

spearheaded global transition for a top Japanese pharmaceutical

customer and led a virtual global team spread across India and

the Netherlands.

Sarvesh is also a member of the ConSPIC scientific committee.

He is a renowned speaker and was invited by the Dutch

Parliament to express his views on the topic "How the

Netherlands can achieve its target of energy efficiency by 2020".

In 2013, he visited the European Commission in Brussels and

heard from the Director-General on how the EU is organized and

how to do business in Europe. He was also invited by The Hague

Institute for Global Justice to attend a seminar on "Dutch Foreign

Policy". He attended the Isha INSIGHT program in November

2014 and had the privilege to meet renowned people such as

Ratan Tata, Kiran Bedi and Ramcharan and hear their views on

how to scale up businesses.

Sarvesh is also very actively involved with a number of NGOs

and is a regular contributor to many of their teaching initiatives.

He was invited in May 2015 for a guest lecture to address the

Faculty Development Workshop at Anna University. In October

2015, he was invited to the House of Lords, UK Parliament, to

attend the London Global Convention.

Sunil Bhatia is a Global Business Partner for TCS’ Life Sciences

Advanced Drug Development (ADD) Platforms, responsible

for consulting, solution-ing, development, sales and marketing

activities of TCS’ ADD Platforms.

Sunil has two decades of extensive international experience in IT

services and business solutions; including a decade of expertise

in the Life Sciences and Healthcare domain. Sunil has triumphed

challenging engagements in sales, delivery and operations

space; working in different capacities across the globe including

client relationships, heading deliveries/operations and executing

complex transformational programs.

Sunil is an active participant in various global conferences,

representing TCS at the Society of Clinical Data Management

(SCDM) San Diego, the World Drug Safety (WDS) Munich, Future

of PV Round-table Berlin, etc. during 2016.

Sunil is a graduate from India’s premier engineering college,

Indian Institute of Technology (IIT), Varanasi and is currently

pursuing his executive MBA from premier management college,

the Faculty of Management Studies (FMS), New Delhi.

KeynoteWelcome & Overview of PhUSE09:45–10:1509:00–09:45


Speakers and abstracts Speakers and abstracts

Mayank Anand, INC Research

Abstract

The advancement of technology led the pharmaceutical industry

to realize the inefficiencies in recreating processes and metadata

from scratch every time as well as the overlap in data elements

across studies. It was also observed that there are inconsistent

methods for collecting specific data elements that seem simple

on the surface. These nonstandard data, with extreme variability

and unpredictability of the format and content, present a major

obstacle to timely, consistent, and efficient review of data by

health authorities globally.

As a result, over the last decade the pharmaceutical industry

has attempted to work toward a common data standard, with

the goal of accelerating drug development by improving the data

collection, transformation, analysis, and submission process.

However, the efforts to define and adopt industry-wide standards

have their challenges in terms of quality, cost, and time.

This presentation will focus on the role of clinical data standards,

highlighting the benefits, stakeholders involved, challenges, and

the road forward. It will also cover how data management is

integrated into clinical data standard development.

Biography

Mayank Anand currently works for INC Research as Director,

Data Operations Technical Services under Biometrics, heading

the APAC region. Mayank brings with himself over a decade’s

experience in the clinical industry across all phases of

clinical trials managing biometrics (data management, clinical

programming and biostatistics). He has played some very

important roles in vendor organizations for three out of the top

five pharma/biotech companies in the world. Over the years, he

has worked for top 10 sponsors, and managed larger biometrics

accounts to provide effective and efficient clinical services.

Mayank has been part of reputed companies such as TCS,

Cognizant and Accenture. He was also associated with

the Human Genetics and Biotechnology faculty of T John College

(Bangalore University), as well as being on the visiting faculty

for several clinical research colleges such as ICRI, CREMA,

and so on.

Mayank has degrees in human genetics and biotechnology, a

master’s in biotechnology and an Honors in Genetic Engineering.

He was Session Chair for the SCDM India 2015 and SCDM

Global 2016 Conferences, invitee for European Leadership meets

for the SCDM 2015 Conference, and Conference Chair for the

SCDM India 2016 Conference. He has also been a member of the

SCDM India Steering Committee.

Mayank has also published multiple white papers across

organizations and pharma journals. His latest paper publication

in PharmaReview was on Business Intelligence in CDM, and he

has also published papers on Digital Forces in Clinical Domain

and Remote Patient Monitoring and Care. In addition to this, he

has also written key blogs on RBM, clinical analytics and clinical

programming.

Data Standards in Clinical Research: Present Scenario, Challenges and Future Directions

10:45–11:15

Mukesh, Government of India

Abstract

A study of sources of finance which households resort to

in order to meet the cost of being hospitalized may assist

policymakers working towards providing financial security

against hospitalization expenses to the masses. An attempt

has been made to study the sources of finance for hospitalized

treatment at an individual level based on criteria such as level

of living, socio-economic background and level of care in

India, both nationally and at State level. It has been found that

household income or savings are not sufficient to meet the cost

of hospitalized treatment and people have to borrow or arrange

finances by other means. Further, to analyze the “treatment with

regard to medical advice before and after hospitalization in India”,

the authors have used two approaches – descriptive and logistic

analyses – both at national level and also at State level. The

analyses reveal that a very high percentage of hospitalized family

members are not treated upon medical advice before being

hospitalized in India. However, an improved approach towards

treatment upon medical advice after hospitalization has been

observed.

Biography

Mukesh is Deputy Director, Infrastructure and Project

Monitoring Division at the Ministry of Statistics and Programme

Implementation (MOSPI) and belongs to the Indian Statistical

Service 2007 cohort. As a statistician with nearly nine years’

experience, he specializes in handling large-scale data, analysis

and application of econometric methods for policy formulation.

He completed his MSc Statistics from the University of Delhi

and BSc Statistics from Banaras Hindu University. At the

MOSPI, he is primarily responsible for monitoring several

central projects worth, or more than, Rs 150 crore and works

closely with the PMO, Cabinet Secretariat, NITI Aayog on

infrastructure performance projects. He is also in charge of the

online monitoring system e-samiksha. He was previously Deputy

Director at the Ministries of Road Transport and Highways and

Shipping, where he undertook large-scale data analysis and also

worked on developing a Port Performance Index for the Ministry

of Shipping. He is a notable research scholar who has published

17 papers in diverse areas of agriculture, poverty, consumer

expenditure, health, education, employment and sanitation in

renowned journals which include the Journal of Educational

Planning and Administration, the Economic and Political Weekly

and the Journal of Quantitative Economics.

Data Analysis of Sources of Finance and Treatment With Regard to Medical Advice

10:15–10:45



Shrishaila Patil, PPD

Abstract

SDTM provides a standard for organizing and formatting data to

streamline processes in collection, management, analysis and

reporting. Implementing SDTM supports data aggregation and

warehousing; fosters mining and reuse; facilitates sharing; helps

perform due diligence and other important data review activities;

and improves the regulatory review and approval process. One

criticism of the SDTM standards is that they are continually

changing, with new versions released frequently. CDISC claims

that SDTM standards are backward compatible. According to

the CDISC SDS Team, CDISC standards evolve, as any standard

does. This presents a number of implementation challenges to

industry. A small change in SDTM could have a huge impact on

the ADaM (Analysis Database), Tables, Figures and Listings and

the Define package. This paper focusses on best practices for

Study Data Tabulation Model (SDTM) standards implementation

to gain efficiency and avoid rework in downstream steps.

Important considerations in SDTM conversion for both ongoing

and legacy studies will be discussed, as well as a list of common

issues and possible proactive measures which can be taken at

each step of SDTM mapping.

Biography

Shrishaila Patil is a programming manager in the Department

of Biostatistics & Programming at PPD Bangalore. He obtained

his MSc in Biotechnology from Bangalore University in 2004.

He has 12+ years of end-to-end experience, which includes

cancer research, bioinformatics, clinical database design, CRF

development, edit checks, SDTM, ADaM and TFL programming.

His area of expertise is in SDTM standards, and he has

contributed as a programmer, SME and trainer in various stages

of his career. He was one of the pioneer members in setting up

the PPD Bangalore Office for Biostatistics & Programming. He

has been actively involved in recruitment, onboarding, training,

global resourcing, project management and line management.

CDISC SDTM Standards Implementation – Common Challenges and Best Practices

12:00–12:30

Neha Srivastava & Gaurab Chakraborty, Chiltern

Abstract

Over the past decade pharmaceutical companies and regulatory

agencies have been laying emphasis on optimizing the need for

data standards across the industry.

The Food and Drug Administration (FDA) has launched a

multilayer initiative called the Therapeutic Area Standards

Initiative Project Plan, to provide guidance on the development

and implementation of therapeutic area standards. It explains

the collaborative development and testing approach of the TA

standards and provides guidance to industry. This Initiative also

unveils some of the common risks faced during the development

of TA standards and the risk mitigation strategies implemented

by the governance body.

As per this Initiative, the key therapeutic areas have been

identified, and specific standards have been developed and

documented in the respective Therapeutic Area User Guide

(TAUG). The TAUGs explain the most common data needed

specific to the indication; they provide examples of the endpoints

and their representation in form of the SAS datasets and they

also capture the concept map about how a subject is treated

when it meets a certain endpoint.

These therapeutic area standards, if implemented appropriately,

will ease the reporting of therapeutic area specific elements.

These standards can also aid in standardizing the designing of

eCRF for these specific elements and hence cover the gaps for a

successful clinical trial life cycle.

Biography

Neha Srivastava is Assistant Manager of Statistical Programming

at Chiltern Clinical Research India Pvt. Ltd. She holds a

postgraduate degree in bioinformatics and a Bachelor of

Technology in Biotechnology. Neha began her professional

career at GlaxoSmithKline and has been involved in analysis

and reporting of clinical trials since 2008. She joined Chiltern

Clinical Research India Pvt. Ltd. in September 2015. Neha has

expertise in leading reporting of late-phase clinical trials in

various therapeutic areas. Her other areas of expertise are

project management, training and development and process

improvement.

Gaurab Chakraborty is Director of Statistical Programming

at Chiltern Clinical Research India Pvt. Ltd. He brings over

12 years’ experience in a variety of roles within biostatistics

and programming teams. Gaurab holds a bachelor’s degree

in statistics and a master’s in computer science. He joined

Chiltern in early 2010; prior to this, he worked at GlaxoSmithKline

Pharmaceuticals. In his current role, Gaurab is responsible for

statistical programming. He is a CDISC enthusiast and one of

the founding members of the Asia-Pacific CDISC Coordinating

Committee (AP3C). He has made several presentations in

industry and academia including at CDISC Asia-Pacific and

Japan Interchanges. He is also actively involved in training people

on data standards.

Use TA Guidelines to Optimize Your Standardization Efforts

11:30–12:00



Prasanna Parthasarathy & Debasis Sahu, ICON

Abstract

The Clinical Data Standards Initiative, in collaboration with

CDISC (Clinical Data Interchange Standards Consortium), aims

to develop industry-wide data standards in priority Therapeutic

Areas (TAs) to support the exchange and submission of clinical

research and metadata, while improving patient safety and

outcomes. Data standardization enables more consistent data

collection in clinical studies, leading to more efficient studies

with higher quality data, which ultimately leads to improved

knowledge about safety and efficacy of the compound, thereby

facilitating the demonstration of traceability of data and enabling

more efficient regulatory review. Further, the accuracy in data

standardization plays a key role between the data collection and

the data analysis. There are various programming quality checks

through which the standardization can be streamlined to increase

the accuracy of the collected data, such as “Listing subjects

with more gap {i.e. more than 5 days} between planned visit day

(VISITDY) and actual assessment day (XXDY)” and “Improved

mapping techniques for external data”. The Clinical Data

Standards Initiative therefore provides a foundation or platform

that will enable data aggregation, cross-study analysis and end-

to-end data flow, thus providing many benefits to stakeholders.

Biography

Prasanna Parthasarathy is a senior clinical data programmer,

Clinical Data Services and has been working at ICON for

over three years. He has over seven years’ experience in

the clinical research industry and in SDTM programming.

He holds a bachelor’s degree in pharmacy and a master’s in

business management (distance education). Prior to joining

ICON, Prasanna worked at organizations including PRA Health

Sciences, Accenture and Thomson Reuters.

Debasis Sahu earned his MPharm in Pharmacology from BPUT

university, Odisha in 2011. He initially continued his clinical

research exposure and later joined ICON as a clinical data

programmer on the SAS platform, in 2014. He has experience

in multiple therapeutic areas in data management and delivery

of clinical trial data. He also transforms the site-collected raw

data to the standard outputs, in accordance with the CDISC FDA

SDTM standards.

Clinical Trials and SDTM Standards14:00–14:30

Puja Kawle, Cytel

Abstract

In this paper, the author will share her experience about the

most common issues identified in metadata submissions, during

the JumpStart of any regulatory submission. The author will

further provide insights into handling these issues. Some of the

challenges faced while creating submission-ready metadata

documents will be discussed. Originally, when the FDA received

submission data, reviewers would spend a great deal of time

assessing the quality of the submitted data. Months were wasted

while reviewers completed data quality reviews and sent data

back to sponsors for correction. To overcome these drawbacks,

in 2002, the FDA launched its first CDER 21st Century Review,

a six-step process for better and more efficient management

of the review process. One of the FDA’s primary goals was to

set up data standards, to facilitate an efficient and standardized

submission process. In December 2014, the FDA announced

electronic submission of future applications and conformance to

the CDISC data standards for study data submission. The FDA

has operationalized the JumpStart service to this effect. In the

initial stages of submission data review, DataFit assessments are

performed as part of the JumpStart service, using automated

analysis tools. This helps reviewers understand any data-

quality issues impacting their review process, way in advance,

consequently saving precious review time.

Biography

Puja Kawle has been a senior statistical programmer at Cytel

since June 2012 and has more than eight years’ experience in the

clinical domain. At Cytel, Puja has working experience in activities

such as CRF annotation, lookup creation, SDTM & ADaM dataset

creation/validation, TFL generation and SDTM submission

activities, namely Define-XML/pdf, acrf.pdf, sdrg.pdf creation.

CDISC SDTM and SDTM Define-related activities are her core

competencies. Prior to joining Cytel, Puja was Senior Technical

Analyst at PAREXEL International (Hyderabad, India). She worked

on CDMS database set-up activities, edit checks specifications

and creating transfer specifications and datasets in adherence

to CDISC SDTM as well as sponsor-specific standards. Before

PAREXEL International, Puja worked as Quality Control Associate

at Tata Consultancy Services (Mumbai, India). Her responsibilities

included functional QC of InForm edit checks, SAS dataset

transfers and SAS checks.

SDTM Submission Package: What Lies Beneath?

12:30–13:00



Arnab Goswami, QuintilesIMS

Abstract

A growing need for standardizing nonclinical data resulted in

the creation of SEND, the Standard for Exchange of Nonclinical

Data, by the FDA in early 2003; and the pilot project launched

in 2007. In the past few years, CDISC standards for clinical trial

data analysis, especially SDTM and ADaM, have rapidly evolved

and the pharmaceutical industry has gradually accepted these

standards because of regulatory mandate. Now, the US Food

and Drug Administration has made it mandatory for raw data of

toxicology animal studies started after December 18, 2016 to

support submission of new drugs to be submitted to the Agency

using SEND. The Japanese PMDA will implement the use of

SEND by 2020, and the EMA has also expressed their interest

in going in the same direction. As a result, a renewed interest

for SEND is gaining pace. To better comply with the regulators

and submission process, it would be absolutely necessary to

understand this standard well. For the same reason, demand for

experts in this field will grow fast, and a consulting service for

SEND is expected to generate new business for CROs and other

software service provider companies too.

Biography

Arnab Goswami is a seasoned professional with 10+ years’

experience in the life sciences industry, and has been working in

the clinical programming arena for the last six and a half years.

He has worked in different therapeutic areas including respiratory

disease, neurological disorders, diabetes and oncology and

has exposure in implementing CDISC standards. Currently

with QuntilesIMS India, Arnab has previously worked at TCS,

Cognizant and pharmaceutical company Lupin. Originally from

Kolkata, West Bengal, he lives with his family in Bangalore. He

is an avid biker and spends his free time with his child or doing

social work.

SEND: A New Avenue for Data Standards15:00–15:30

Krupali Ladani & Sangram Parbhane, doLoop Technologies

Abstract

CDISC-compliant clinical trial data submission is more of a

mandatory process, and highly recommended by regulatory

authorities. One of the required standards that sponsors must

submit for regulatory submissions is SDTM. SDTM represents

the collected data in specified format; however, this data is

not analysis-ready. That’s where ADaM comes into play. ADaM

– Analysis Data Model – defines the dataset and metadata

standard that supports creation of statistical analyses and

traceability of these analyses back to SDTM. It is often termed

that ADaM is complex and possesses too many composite

derivations; however, when we understand that ADaM is the key

for data analysis and important for justifying the entire clinical

trial, it no longer looks complex or lengthy and is worth spending

time on. As an ADaM SME or as an ADaM programmer, the

biggest challenge is where do I start? This question arises very

frequently regardless of your role in the CDISC ADaM life cycle.

This presentation will take you through ADaM basics and where

you start for:

ADaM Specification Development

ADaM Dataset Programming

ADaM QC Traceability from SDTM.

Biography

Krupali Ladani has five years’ experience as a SAS programmer

and currently works as a senior clinical SAS programmer at

doLoop Technologies. She is BASE and Advance SAS Certified

and holds a master’s degree in pharmacology. Throughout her

career, Krupali has been fortunate to be involved in all aspects of

the CDISC life cycle. Her expertise includes: SDTM specification

generation, SDTM programming and validation, ADaM

programming and validation and TFL SAS programming tasks

for safety and efficacy analysis. Her therapeutic area experience

includes neuroscience, respiratory, asthma, cardiovascular and

vascular diseases. She has experience working with multi-

cultural environments, interacts cross-functionally and manages

resources and projects. Before joining doLoop Technologies,

Krupali worked at PPD and MMS Holdings.

Dr. Sangram Parbhane currently works as an associate clinical

SAS programmer at doLoop Technologies. He previously worked

as a trainee SAS programmer at CYTEL. His experience includes

creating SDTM specifications and SAS programming for various

dataset creations. He gained his Bachelor of Dental Surgery

(BDS) from Maharashtra University of Health Sciences (MUHS),

Nashik. Sangram is a certified business analyst, and is pursuing

his MBA from Pune University, where he gained a gold medal in

his MBA examinations.

ADaM: Where Do I Start?14:30–15:00


Speakers and abstracts

Jyotirmay Shukla, TCS

Abstract

The need of adherence to data standards has been understood

by many pharmaceutical companies. However, companies often

face challenges in making their best use. The data standards

proposed by CDISC have been widely accepted and hence

the challenges that companies face in implementing these

data standards are of grave importance. The author would

like to share their thoughts on what CDISC provides and what

pharmaceutical companies want to get their drug approval more

competitive through use of data standards. It is very important

to balance this equation as it is the foundation stone of clinical

data standardization and its optimization. This paper will discuss

how far the industry has come in optimizing the use of CDISC

data standards, what more can be achieved in this area and the

challenges faced in realizing them.

Biography

Jyotirmay Shukla completed his engineering studies in

electronics and communication. Thereafter, he joined Tata

Consultancy Services, where he currently works as an IT analyst.

During his five-year career experience, he has worked with

various customers across the life sciences domain as a clinical

data manager and a SAS developer.

Challenges in Optimizing the Use of Data Standards

15:30–16:00

ContributorsThank you to all our contributors for their generous support

Things to come

Looking forward

March CSS US

Silver Spring, USA

19th–21st March

February USA SDE

Foster City, CA

23rd February

July USA SDE

North Chicago, IL

Date TBC

April USA SDE

Boston, MA

27th April

India SDE

Bangalore

22nd April

Japan SDE

Tokyo

14th April

May Germany SDE

Frankfurt

Date TBC

Switzerland SDE

Basel

Date TBC

UK SDE

London

Date TBC

China SDE

Beijing

Date TBC

June Denmark SDE

Copenhagen

Date TBC

CSS EU

London, UK

19th-20th June

USA SDE

Raritan, NJ

Date TBC

India SDE

Hyderabad

Date TBC

August USA SDE

Whippany, NJ

Date TBC

Japan SDE

Tokyo

Date TBC

September France SDE

Chilly-Mazarin

Date TBC

October PhUSE Annual

Conference

Edinburgh, UK

8th–11th October

November Belgium SDE

Beerse

Date TBC

USA SDE

Chapel Hill, NC

Date TBC

India SDE

Mumbai

TBC

China SDE

Shanghai

Date TBC

Visit the PhUSE website for further information – phuse.eu/single-day-events-2017

16 | PhUSE Single Day Event | Delhi 2017

Conference Chair Jules van der Zalm, OCS ConsultingConference Co-Chair Katja Glaß, Bayer PharmaFor more information visit the PhUSE website phuse.eu/annual-conference.aspx

Annual Conference

Edinburgh Castle

Digital Innovation in Healthcare8th–11th OctoberEdinburgh International Conference Centre

Edinburgh 2017

Optimizing the Use of Data Standards 18th February … SDE Delhi Brochure WEB .pdfOptimizing the Use...

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