Best Practices for Interventional Cardiovascular Medical Device Trials in APAC

Clinical Trials, Emerging Market, Medical Device,
  • Tuesday, October 01, 2019 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

The Asia-Pacific region (APAC) is prepared to be key in addressing one of the world’s great health concerns. In our aging society, heart disease has become one of the most significant health problems worldwide. Its incidence is forecast to increase steadily as the number of people aged 60 and older is expected to double by 2025 and to triple by 2050. This aging will occur disproportionately in the Asia-Pacific region, which is predicted to account for half of the world’s cardiovascular disease burden by mid-century. This disease’s migration signals the need to anticipate and leverage the region’s role in therapeutic development and clinical trials.

The demographic shift and other factors point to the fast-growing region — which is expected to surpass the European Union in 2020 as the world’s second-largest med-tech market (after the United States) —becoming a major force in cardiovascular clinical trials.

Bringing interventional cardiac devices to market is a large and complex opportunity, and sponsors seeking to bring implantable cardiovascular products to the APAC market face significant challenges in designing and conducting clinical trials for stents, valves, pacemakers, ventricular assist devices and novel technologies.

In this webinar, the featured speakers will explore best practices for interventional cardiovascular medical device trials in APAC, considering:

  • Opportunities and challenges in clinical investigation of medical devices
  • The impact of a changing regulatory environment
  • Considerations in study conduct such as treatment protocols, data, endpoints and selection of principal investigators, sites and patients
  • Reimbursement strategies
  • Vendor selection

Speakers

http://Sundeep%20Shrivastava,%20APAC

Sundeep Shrivastava, Executive Director, Strategic Development, Medical Device & Diagnostics, APAC, Premier Research

Sundeep Shrivastava is responsible for advancing Premier Research’s medical devices and diagnostics business in the Asia-Pacific region. He has more than 20 years of clinical and commercial experience in the medical devices and contract research organization (CRO) industries, spearheading business operations and clinical research projects involving medical devices, including pivotal first-in-human studies and post-marketing studies in Asia.

Prior to joining Premier Research, Mr. Shrivastava held key positions in the areas of clinical research, portfolio management, as well as marketing and business development with Guidant Corporation, Abbott Vascular and IQVIA. He has extensive experience in coordinating with local regulatory bodies regarding approvals for clinical studies and commercializing products in Asia. In the last decade, he has operationalized more than 50 medical device clinical projects which include first-in-man plus pivotal and post-marketing studies in cardiovascular, orthopedics, nephrology, surgery and ophthalmology devices.

In an honorary capacity, he is an associate with Singapore Biodesign, Enterprise Singapore and the Centre for Innovation in Healthcare at NUHS, Singapore.

Message Presenter
http://Joanne%20Emmett,%20Premier%20Research

Joanne Emmett, Vice President, Medical Device & Diagnostics, Premier Research

Joanne Emmett has been part of the clinical research industry for 20+ years with a keen focus on operational design and delivery. Ms. Emmett started her career in academia within transplant research and proceeded on to cardiovascular research involving valve and imaging trials. Once joining the CRO business space in 1995, she was engaged as a CRA, LCRA and project manager working on trials in CNS, oncology, respiratory, cardiovascular, and with a keen focus within the medical device and diagnostic realm. Ms. Emmett took her front-line delivery experience to the next level and moved into oversight and department leadership specializing in clinical and project management delivery, spending time at PRA and joining Premier Research in early 2011. Since joining Premier Research, Ms. Emmett, has been responsible for the operational delivery structures and planning for both clinical and project management. She has focused on the key needs and standards within therapeutics and medical device and ensuring core process designations for staffing and oversight, including the unique regulatory and scientific avenues required for medical devices.

Message Presenter

Who Should Attend?

This webinar would appeal to individuals working at medical device & diagnostics companies with the following or related job titles:

  • Directors/Heads of Clinical Operations
  • Directors/Heads of Outsourcing
  • Project Directors

What You Will Learn

Attendees will gain insights into:

  • The emergence of cardiovascular trials in the APAC
  • Opportunities and challenges in clinical investigation of medical devices
  • The impact of a changing regulatory environment
  • Considerations in study conduct such as treatment protocols, data, endpoints and selection of principal investigators, sites and patients
  • Reimbursement strategies
  • Vendor selection

Xtalks Partner

Premier Research

Premier Research, a mid-size clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments.

As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.

Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.

Visit premier-research.com.

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