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Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.
Showing posts with label ethics. Show all posts
Showing posts with label ethics. Show all posts
Tuesday, September 17, 2013
DIA's 8th Annual Conference - The New Clinical Research Environment in India
Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.
Friday, April 19, 2013
What are the ethical considerations in conducting clinical research?
Overview of Drug Development
June 23 from 9:00AM – 5:00PM in Boston
This tutorial will provide an introduction to the drug development process under FDA and ICH Guidelines, including how various parts of companies fit into the overall process of pharmaceutical development.
Instructor:
George H. D'Addamio, PhD
President
PharmConsult Inc., United States
What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.
Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.
Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.
June 23 from 9:00AM – 5:00PM in Boston
This tutorial will provide an introduction to the drug development process under FDA and ICH Guidelines, including how various parts of companies fit into the overall process of pharmaceutical development.
Instructor:
George H. D'Addamio, PhD
President
PharmConsult Inc., United States
What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.
Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.
Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.
Thursday, December 13, 2012
第三届最佳伦理培训-早期报名享优惠！
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Friday, November 2, 2012
#diaIndiaAM2012 Saturday, November 3 Pharma sessions in Hyderabad, India
DIA’s 7th Annual Conference Discovery through Commercialization: Innovative Strategies for Individualized Healthcare
Nov 1 2012 8:30AM - Nov 4 2012 5:00PM | Hyderabad International Convention Center Novotel & HICC Complex (Near Hitec City) PO Bag 1101 Cyberabad Post Office Hyderabad 500081 IndiaSaturday, November 3, 2012
9:00AM - 10:30AM
Session 10: Lead Discovery
Session Chair(s):
- chair
- Raman Govindarajan
Senior Vice President, Development & Translational Medicine
Jubilant Biosys, India
Speaker(s):
- presentation
- Impact of Structural Biology on Drug Discovery Ajith Kamat
Head, Strategic Research Partnership
Pfizer Ltd., India
presentation
- Lead Identification and Optimization in Small Molecular Drug Discovery: SBDD Case Studies Vellarkad N. Viswanadhan
VP
Jubilant Biosys, India
presentation
- Application of Parallel Medicinal Chemistry Strategies for Rapid and Efficient Optimization of Adenosine A1 Receptor Modulators Representative Invited
United States
9:00AM - 10:30AM
Session 11: Go to InvestorsSession Chair(s):
- chair
- R. B. Smarta
Founder and Managing Director
Interlink Marketing Consultancy Pvt. Ltd., India
Speaker(s):
- presentation
- Mergers or Partners D. A. Prasanna
Chairman and Managing Director
Ecron Acunova, Germany
presentation
- Branding: An Essential Tool to Attract Investment Madeline Ducate, MPH,MS
Exec.VP Global Operations
Pharm-Olam International, United States
presentation
- Funding and Investing in New Product Development Anil Kamath
Eli Lilly and Company, United States
9:00AM - 10:00AM
Session 12: Quality Management in ManufacturingSession Chair(s):
- chair
- Sunil Singhai
Vice President - Tech Transfer
Dr. Reddy's Laboratories, India
Speaker(s):
- presentation
- Potent Product Process and Facility Design Sunil Singhai
Vice President - Tech Transfer
Dr. Reddy's Laboratories, India
presentation
- Quality Management Process in Faculty Development Vinay Nayak
President Technical
Alembic Pharmaceuticals, India
presentation
- World Class Manufacturing- A Challenge and Opportunity for the India Pharma Industry Pushpinder Bindra
CEO
Zenith and Beyond, India
presentation
- Case Study: Integration of Patient Needs, and Quality Requirements in Recent Times has Enforced Application of “Quality by Design (QbD)” and “Process Analytical Technology (PAT)” to development of Therapeutic Vaccines Nicholas Cappuccino, PhD,MBA
Global Head, Quality
Dr. Reddy's, United States
11:30AM - 1:00PM
Session 13: Evolving Roles of Personnel Involved in Clinical Trials — Panel DiscussionSession Chair(s):
- chair
- Sam T Mathew
Process Lead-Medical Writing
Accenture Services, India
Speaker(s):
- presentation
- Ajit Nair
Global Head, Clinical Services
TATA Consultancy Services, India
presentation
- Partha Chakraborty, MBA
Director/Head, Pharmacovigilance Center of Excellence
Cognizant, India
presentation
- Shubhadeep Sinha, DrMed,MD
Medical Doctor
Clinical Research & Pharmacovigilance Consultant, India
11:30AM - 1:00PM
Session 14: Lean Six Sigma — Medical WritingSession Chair(s):
- chair
- Nimita Limaye, PhD
Vice President
Tata Consultancy Services, India
chair
- Helle Gawrylewski, MA
Senior Director, Regulatory Medical Writing
Janssen R&D Companies of J&J, United States
Speaker(s):
- presentation
- Panel Discussion: Thinking Lean in Medical Writing: Driving Change Paul P. Sokol, PhD
Director
Johnson & Johnson Prd., United States
presentation
- Panel Discussion: Thinking Lean in Medical Writing: Driving Change Shashidhar Rao
Head Global Medical Affairs and HEOR, India Operations
Novartis Healthcare Pvt. Ltd., India
presentation
- Offshoring Medical Writing: Lean Project Management Strategy Paul P. Sokol, PhD
Director
Johnson & Johnson Prd., United States
presentation
- Offshoring Medical Writing: Lean Project Management Strategy Seema G. Gurbani
Assistant Manager, Medical Writing
Tata Consultancy Services, India
presentation
- Improving the Sigma Level of Medical Writing Shashidhar Rao
Head Global Medical Affairs and HEOR, India Operations
Novartis Healthcare Pvt. Ltd., India
presentation
- Improving the Sigma Level of Medical Writing Murthy Palli
Operations Manager
Novartis Healthcare, India
11:30AM - 1:00PM
Session 15: Personalized Medicine and Challenges ahead for Biomanufacturing in IndiaSession Chair(s):
- chair
- Subir Basak
President
Jubilant Biosys, India
Speaker(s):
- presentation
- Pharmacogenomics for Personalized Medicine: Optimizing use of Drug and Drug Combinations to Improve Patient Outcome Jugnu Jain
Director
Saarum Sciences, India
presentation
- Quality Control, a Necessary Paradigm when 'Leaning Out' Operations, as Pharmaceutials Shift from the Blockbuster Model to Personalized gene Therapies and Gene-specific Small-molecule Treatments Swapnil Ballal
Quality Lead
Biocon, India
presentation
- BioManufacturing in India Subir Basak
President
Jubilant Biosys, India
2:00PM - 3:30PM
Session 16: Pre-clinical Discovery and DevelopmentSession Chair(s):
- chair
Vishwanath Iyer (Mahesh)
Head, Oncology Biometrics
Novartis Healthcare, India
Speaker(s):
- presentation
- Translational Approaches to Target Validation, Drug Action and Patient Response Characterization Raman Govindarajan
Senior Vice President, Development & Translational Medicine
Jubilant Biosys, India
presentation
- Imaging as a Biomarker in Early Stage Development Smita Pandit
Director, Imaging Operations
Perceptive Informatics, India
presentation
- Pharmacovigilence and Drug Safety Shwetha Kamath
Drug Safety Physician
Accenture, India
2:00PM - 3:30PM
Session 17: Scientific, Regulatory and Ethical Challenges in Advancing Personalized MedicineSession Chair(s):
- chair
- Carol Isaacson Barash
Adjunct Prof. Personalized Medicine, Regis College
Principal, Helix Health Advisors, United States
Speaker(s):
- presentation
- Realizing the Promise of Personalization through Health Care Mass Commercialization Sagar Kamarthi
Associate Professor
Northeastern University, United States
presentation
- Regulatory Challenges for Molecular and Companion Diagnostics Jeffrey N. Gibbs, JD
Director
Hyman Phelps & McNamara, PC, United States
presentation
- Ethical Issues in Individualized Health Care — Seeking Solutions in a Complex World Aamir Shaikh, MD
Founder
Assansa, India
presentation
- Personalized Nutrition: Parallels from Personalized Medicine Emmanuelle Voisin, PhD
CEO and Principal
Voisin Consulting, France
2:00PM - 3:30PM
Session 18: Data and Semantic Interoperability in Personalized MedicineSession Chair(s):
- chair
- Nikhil Kumar
President
Applied Technology Solutions, Inc., United States
Speaker(s):
- presentation
- Semantic Interoperability, Data and Personalized Medicine Nikhil Kumar
President
Applied Technology Solutions, Inc., United States
presentation
- CDASH Standards Library Implementation Across Multiple EDC Systems and its Potential Benefits Sunish Raj
Manager, GRO
PAREXEL International, India
presentation
- Harmonization of Clinical Data Standards Senthil Raja
Manager, Clinical DB Programming
PAREXEL International, India
4:30PM - 6:00PM
Session 19: Current Challenges in Clinical Development in IndiaSession Chair(s):
- chair
- Viswanath Iyer (Mahesh), PhD
Head, Oncology Biometrics
Novartis Healthcare Pvt. Ltd., India
Speaker(s):
- presentation
- Challenges in Conducting Clinical Trials in India: Sponsor's Perspective Bobby George, PhD
Asst. VP, Regulatory Affairs
Reliance Life Sciences, India
presentation
- T. Balganesh
Distinguished Scientist Head of OSDD Unit
Council of Scientific and Industrial Research (CSIR), India
presentation
- Current Ethics Related Challenges in Clinical Development in India Shoibal Mukherjee, MD,MS
Vice President, Medical
Quintiles, India
4:30PM - 6:00PM
Session 20: Therapeutics — Pharmacology and Applications in Personalise MedicineSession Chair(s):
- chair
- Vishwas Sovani
Revogenex, Inc., India
Speaker(s):
- presentation
- Personalised Medicine Pharmacological basis Vishwas Sovani
Revogenex, Inc., India
presentation
- Therapeutic Applications of Personalized Medicine Mangesh S. Kulkarni, MD
Group Head, DS&E
Novartis Healthcare, India
presentation
- Ready to Use Kits for Personalized Medicine Mukesh Agrawal
Vice President, CRL
Vimta Labs, India
4:30PM - 6:00PM
Session 21: Panel Discussion on Regulatory in ManufacturingTuesday, September 25, 2012
9th Latin American Congress of Clinical Research - Early bird savings extended
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