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DTSTART;TZID=America/New_York:20250729T080000
DTEND;TZID=America/New_York:20250731T220000
DTSTAMP:20251007T035219Z
CREATED:20250616T195235Z
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UID:13619-1753776000-1753999200@osma.net
SUMMARY:OSMA Virtual Summer Series 2025
DESCRIPTION:Join us for the OSMA Virtual Summer Series! \nWHEN: Five sessions taking place July 29 & 31\, 2025 \nWHERE: OSMA Zoom Meeting \nREGISTRATION: Registration has closed.  Please see below for presentations. \nJuly 29th | 11:00am ET: Navigating India’s Healthcare Landscape: A Market Entry Guide for Global Healthtech Manufacturers \nThis insightful 60-minute session with Dr. Viraj Vaidya (bttn) and Dr. Premnath Venugopalan (CSIR-NCL) will provide a quick overview of India’s healthcare product approval landscape (CDSCO\, ICMR\, BIS)\, highlight recent regulatory trends\, and share practical strategies for global healthtech manufacturers entering the Indian market. We’ll cover classification\, approval pathways\, and market entry playbooks\, along with examples and visuals to illustrate key points. \nPresentation: Breaking into India- Healthcare Product Approvals & Market Entry Strategy \nIndia Session Executive Summary \n  \nJuly 29th | 7:00pm ET: Japan’s Medical Device Regulatory Environment: PMDA Pathways and Market Entry Strategies for Orthopedic Manufacturers \nThis 60-minute session with Philip O’Neill (Parkdale Group) will provide a comprehensive overview of Japan’s medical device regulatory environment\, focusing on the PMDA and key approval pathways for market entry. We’ll examine common pitfalls and share practical tips for companies new to the Japanese market\, along with strategic insights that can benefit experienced manufacturers looking to optimize their approach. \nPresentation: Regulatory Landscape and Market Entry Strategies in Japan \nJapan Session Executive Summary \n  \nJuly 31st | 12:00pm ET: Real World Evidence in Healthcare: Insights and Applications from NEST \nThis 60-minute session will provide an overview of NEST’s role in advancing real-world evidence for medical device manufacturers. The presentation will cover who NEST is and their partnership with MDIC\, followed by an explanation of the NESTcc Mark process and how it helps streamline regulatory submissions. Attendees will learn about NEST’s data partner network and how they support evidence generation\, along with real-world examples of successful regulatory submissions including recent PMA approvals and 510(k) clearances across various therapeutic areas. The session will conclude with insights on why partnering with NEST can help manufacturers navigate the FDA review process more effectively\, including their unique ability to address medical reviewer concerns early in the submission process.  We will be joined by Madhu Shetty\, Cori Maegley\, MBA\, MS\, Jill Dreyfus\, PhD\, MPH\, and Jemin Dedania\, MBA\, MS\, RAC. \nReal World Evidence with NEST \nRWE/NEST Session Executive Summary \n  \nJuly 31st | 1:00pm ET: OSMA Business Meeting \nThis 60-minute session will provide OSMA members with comprehensive updates on organizational activities and strategic initiatives. The meeting will feature officer reports and key OSMA updates\, followed by a review of the strategic partner program and discussion of collaborative efforts with other trade associations. Attendees will receive updates on the working group program and participate in planning discussions for future meetings\, including details about the upcoming fall meeting at FDA. This business session offers an essential opportunity for members to stay informed on OSMA’s direction and provide input on organizational priorities. \n  \nJuly 31st | 8:00-10:00pm ET: APAC Medical Device Regulatory Landscape: Strategic Pathways for China\, Korea\, and Southeast Asia Markets \nThis comprehensive 2-hour session will feature subject matter experts from Johnson & Johnson MedTech providing in-depth insights into key APAC market regulatory frameworks. The session will begin with an overview of APAC go-to-market regulatory strategy\, followed by detailed presentations on the regulatory landscapes in China\, South Korea\, and Singapore & Southeast Asia. Each country-specific segment will include dedicated time for Q&A\, allowing attendees to engage directly with subject matter experts who have extensive experience navigating these complex markets. This session is essential for medical device manufacturers looking to understand regulatory pathways\, current requirements\, and strategic approaches for successful market entry across the diverse APAC region.  We will be joined by Daniel Moelands\, PharmD\, MBA (VP RA APAC)\, SeongHee Byun (RA Manager Korea)\, Kai Chang Khoo (Regulatory Affairs Lead Singapore)\, and Elaine Wu (Regulatory Affairs Director China). \nAPAC Session Executive Summary \nSUBMIT SPEAKER QUESTIONS TO: mpc@osma.net
URL:https://osma.net/event/osma-virtual-summer-series/
LOCATION:Maryland
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2025/06/2INTRODUCING-THE-OSMA-VIRTUAL-SUMMER-SERIES-1800-x-1800-px.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20250729T080000
DTEND;TZID=America/New_York:20250731T220000
DTSTAMP:20250814T152135Z
CREATED:20250714T124211Z
LAST-MODIFIED:20250814T152135Z
UID:13668-1753776000-1753999200@osma.net
SUMMARY:OSMA Virtual Summer Series 2025
DESCRIPTION:Join us for the OSMA Virtual Summer Series! \nWHEN: Five sessions taking place July 29 & 31\, 2025 \nWHERE: OSMA Zoom Meeting \nREGISTRATION: Registration is free!  Please log into your member account for executive summaries and presentations. \nJuly 29th | 11:00am ET: Navigating India’s Healthcare Landscape: A Market Entry Guide for Global Healthtech Manufacturers \nThis insightful 60-minute session with Dr. Viraj Vaidya (bttn) will provide a quick overview of India’s healthcare product approval landscape (CDSCO\, ICMR\, BIS)\, highlight recent regulatory trends\, and share practical strategies for global healthtech manufacturers entering the Indian market. We’ll cover classification\, approval pathways\, and market entry playbooks\, along with examples and visuals to illustrate key points. \nJuly 29th | 7:00pm ET: Japan’s Medical Device Regulatory Environment: PMDA Pathways and Market Entry Strategies for Orthopedic Manufacturers \nThis 60-minute session with Philip O’Neill (Parkdale Group) will provide a comprehensive overview of Japan’s medical device regulatory environment\, focusing on the PMDA and key approval pathways for market entry. We’ll examine common pitfalls and share practical tips for companies new to the Japanese market\, along with strategic insights that can benefit experienced manufacturers looking to optimize their approach. \nJuly 31st | 12:00pm ET: Real World Evidence in Healthcare: Insights and Applications from NEST \nThis 60-minute session will provide an overview of NEST’s role in advancing real-world evidence for medical device manufacturers. The presentation will cover who NEST is and their partnership with MDIC\, followed by an explanation of the NESTcc Mark process and how it helps streamline regulatory submissions. Attendees will learn about NEST’s data partner network and how they support evidence generation\, along with real-world examples of successful regulatory submissions including recent PMA approvals and 510(k) clearances across various therapeutic areas. The session will conclude with insights on why partnering with NEST can help manufacturers navigate the FDA review process more effectively\, including their unique ability to address medical reviewer concerns early in the submission process.  We will be joined by Madhu Shetty\, Cori Maegley\, MBA\, MS\, Jill Dreyfus\, PhD\, MPH\, and Jemin Dedania\, MBA\, MS\, RAC. \nJuly 31st | 1:00pm ET: OSMA Business Meeting \nThis 60-minute session will provide OSMA members with comprehensive updates on organizational activities and strategic initiatives. The meeting will feature officer reports and key OSMA updates\, followed by a review of the strategic partner program and discussion of collaborative efforts with other trade associations. Attendees will receive updates on the working group program and participate in planning discussions for future meetings\, including details about the upcoming fall meeting at FDA. This business session offers an essential opportunity for members to stay informed on OSMA’s direction and provide input on organizational priorities. \nJuly 31st | 8:00pm ET: APAC Medical Device Regulatory Landscape: Strategic Pathways for China\, Korea\, and Southeast Asia Markets \nThis comprehensive 2-hour session will feature subject matter experts from Johnson & Johnson MedTech providing in-depth insights into key APAC market regulatory frameworks. The session will begin with an overview of APAC go-to-market regulatory strategy\, followed by detailed presentations on the regulatory landscapes in China\, South Korea\, and Singapore & Southeast Asia. Each country-specific segment will include dedicated time for Q&A\, allowing attendees to engage directly with subject matter experts who have extensive experience navigating these complex markets. This session is essential for medical device manufacturers looking to understand regulatory pathways\, current requirements\, and strategic approaches for successful market entry across the diverse APAC region. We will be joined by Daniel Moelands\, PharmD\, MBA (VP RA APAC)\, SeongHee Byun (RA Manager Korea)\, Kai Chang Khoo (Regulatory Affairs Lead Singapore)\, and Elaine Wu (Regulatory Affairs Director China). \nSUBMIT SPEAKER QUESTIONS TO: mpc@osma.net
URL:https://osma.net/event/osma-virtual-summer-series-2/
LOCATION:Maryland
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2025/06/2INTRODUCING-THE-OSMA-VIRTUAL-SUMMER-SERIES-1800-x-1800-px.png
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