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In this ISSUE

The VA Gets Real on Reform

The Changing Landscape for Clinical Trial Sites

Creating Medicines 'Appropriate for All'

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Industry News
Latest in Business and People News
The latest happenings of the past month in the industry, all in one place.
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Launching Medical Devices in the Japanese Market
- How to navigate regulatory and reimbursement approval

Thursday, October 31, 2019 at 11am EDT
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Novartis Data Manipulation Spotlights Wider Concerns
Regulatory enforcement actions, policy updates, and new guidelines show that ensuring the reliability of clinical data is an ongoing priority.
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GrantPlan: Create Grant Budgets with Confidence and Accuracy
Thursday, October 10, 2019 at 11am EDT
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Calendar
/ 16th Annual Patient Summit USA – 10/2-10/3 /
/ Rare Diseases & Orphan Products Breakthrough Summit – 10/21–10/22 /
/ eCOA/ePRO 2019 – 10/29 /
/ Risk-Based Trial Management and Monitoring –11/13–11/14 /
/ Clinical Trial Legal and Contracting Forum – 12/10–12/11 /

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Successful Early Phase Drug Development of mAb Drugs
Europe: Thursday, September 26, 2019 at 3pm BST | 4pm CEST
North America: Thursday, October 3, 2019 at 11am EDT | 10am CDT | 8am PDT
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Emerging Biopharma Tackles the Opioid Crisis
Dr. Steven Fox, CEO of Akelos Inc., discusses the challenges of developing new non-opioid medical products as the need intensifies and the crisis worsens.
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Begin with the End in Mind: The Strategic Benefit of Coordinating Site Budgeting, Contracting, & Payments
Wednesday, October 2, 2019 at 11am EDT
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Opinion
Why Patient-Centric Clinical Trials Are Easier Said Than Done
Michael Keens, COO of Firma Clinical, explores the beginning of patient centricity, common misconceptions related to its implementation, and offers steps to improve the ability to achieve patient centricity within drug development.
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How AI/ML and advanced techniques are enhancing clinical development
Lessons learned from use in study design, patient and site ID, safety, and risk-based monitoring
Tuesday, October 1, 2019 at 11am EDT
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Proliferation of Rare Disease R&D Necessitating Novel Strategies
Interest in benchmark data on the scope, performance, and economics of rare disease drug development efforts has grown.
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Ask the editor
Lisa Henderson
Editor in Chief
LHenderson@mmhgroup.com

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Todd Baker
Group Publisher
tbaker@mmhgroup.com
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