PROGRAM & EDUCATION (Hyderabad)

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SCDM’s  Single Day Event (Hyderabad) Program

Time Session
09:30 AM – 09:45 AM Inauguration
09:50 AM – 10:35 AM Key Speaker 1 -Michael Goedde: Clinical Data Management and RWE studies: CDM’s next Frontier
10:35 AM – 11:05 AM Tea Break
Parallel Sessions
11:05 AM – 01:05 PM Industry Workshop (ICON) Academic Workshop:(INC and INVENTIV Health)
01:05 PM – 02:00 PM Lunch Break
02:00 PM – 04:00 PM Industry Workshop:(ICON: Analytics and Automation in the Clinical Domain) Academic Session (INC & INVENTIV Health: Application of CDISC standards in RWE)
04:00 PM – 04:30 PM White Paper Presentation
04:30 PM – 05:00 PM Tea Break
05:00 PM – 05:45 PM Key Speaker 2 (Vishwanath (Mahesh) Iyer) : The real deal about real world evidence: Impact on drug development and healthcare 
05:45 PM – 06:00 PM Mementos for the speakers and Vote of Thanks

We are currently seeking the submission of Whitepapers. The closing date for the submission of abstracts is 22nd September 2017.  The results from submitted abstracts will be announced on 29th September 2017. The subject matter of these whitepapers will consider the following topic :

  1. Use of Real World Evidence to support regulatory Decision making for Clinical Research 
  2. Regulatory and Privacy Challenges in the collection and usage of Real World Data for decision making 

To submit, share abstracts with Mayank Anand (mayank.anand@incresearch.com), Dinesh Pillaipakkamnatt (dinesh.pillaipakkamnatt@novartis.com) and Anil Golla (anil.golla@cytel.com). 

Keynote Speaker : Michael Goedde

Michael Goedde is a Certified Clinical Data Manager with more than 26 years of experience in the pharmaceutical and biotechnology industry.

He started his career in 1990 at Hoechst, a predecessor company of Sanofi-Aventis, in Frankfurt (Germany). After supporting numerous submissions and leading programs through all stages of clinical development, Michael then chose to join the Aventis Headquarters in Bridgewater, New Jersey (US) in 2001 as a Global Project Data Manager and Global Therapeutic Area Lead for Oncology and Neurology. After leaving Aventis in 2005 he joined Kos Pharmaceuticals in Florida for 2 years before accepting the position of Senior Director of Clinical Data Management at Human Genome Sciences (HGS) in Rockville, Maryland. After the GSK takeover of HGS in 2012, he joined MedImmune(Astra Zeneca) as Head of CDM, where he re-built the CDM department. In 2014 he decided to join PAREXEL International as VP, Global Data Operations. Michael holds a degree in Computer Sciences and is a recognized member of the Society for Clinical Data Management (SCDM). He has presented and chaired sessions on numerous occasions at conferences including an invitation from the FDA in 2010 to present on “Industry Best CDM Practices” at the Center’s Bioresearch Monitoring course.

Keynote Speaker : Vishwanath (Mahesh) Iyer

Vishwanath (Mahesh) Iyer is currently Site Head, Biostatistics at Novartis, Hyderabad heading up a team of Biostatistician.  He has a Ph.D. in Statistics from Temple University, Philadelphia.  Mahesh has been involved in analyzing and reporting clinical trial data since 1998 with companies like Boehringer-Ingelheim and Bristol Myers Squibb, and specifically for Oncology studies since 2000.  In addition, Mahesh has also been active in the statistical research community with a primary focus on multiple comparison procedures.  Mahesh is actively involved in teaching at multiple institutes in India, adjunct faculty at Institute of Ayurvedic and Integrated Medicine at Bangalore, served on the Advisory Council of India for the DIA, serves as the Secretary for the Indian Association for Statistics in Clinical Trials (IASCT).  He also serves as the Vice-President of the International Indian Statistical Association – India chapter, on the Board of Studies for Statistics at Manipal University and was the co-editor for a pharmaceutical journal.

For more information about this event, please contact:

Tel: +32 2 740 22 37

Fax:+32 2 743 15 50
E-mail: info@scdm.org