October 2015
Xavier Health Combination Products Summit
Join FDA and Industry Experts Discussing Solutions to Current Combination Product Implementation Challenges Deep Dive on Pressing Issues Sharing of “Tribal Knowledge” from FDA Officials and Industry Experts Pharma and Device Professionals learn from each other Click here for more information and registration details.
Find out more »January 2016
MedCon 2016
MedCon 2016, presented by Xavier Health, brings the global Medical Device community together to openly discuss the most pressing issues facing our industry. You have the opportunity to influence decisions and have your voice heard, as you interact with leading FDA officials and field investigators along with global industry experts. Inspiring Collaboration… •Feel the Purpose-Driven nature of this conference as soon as you enter the room. •Expect orchestrated engagement with your peers across the industry on topics you are passionate…
Find out more »March 2016
PharmaLink presented by Xavier Health
The PharmaLink conference presented by Xavier Health seeks solutions to important and complicated issues by aligning with the strategic priorities of the Food & Drug Administration. We help participants create links to drive new thinking. The solutions might not be evident within our industry, so we explore beyond industry, beyond borders, and beyond comfort zones. Don’t miss this opportunity to join your colleagues and global regulators from around the world so you can make a meaningful difference for your organization…
Find out more »November 2016
Combination Products Summit 2016
The Combination Products Summit will be held at the Award Winning Cintas Center at Xavier University Inspiring Collaboration… •Feel the Purpose-Driven nature of this Summit as soon as you enter the room. •Expect orchestrated engagement with your peers across the industry on topics you are passionate about. •Find attendees openly sharing their expertise to help advance the industry in collaboration with regulators. •Work side-by-side with regulators to deepen the understanding on both sides of challenges and opportunities. Leading Innovation… •Identify solutions that…
Find out more »March 2017
FDA Xavier PharmaLink Conference
The FDA / Xavier Health PharmaLink Conference seeks solutions to important and complicated issues by aligning with the strategic priorities of the Food & Drug Administration. PharmaLink helps participants create links to drive new thinking. The solutions might not be evident within the industry, so PharmaLink explores beyond the industry, beyond borders, and beyond comfort zones. Don’t miss this opportunity to join your colleagues and global regulators from around the world so you can make a meaningful difference for your organization and our…
Find out more »May 2017
MedCon 2017 presented by Xavier Health
MedCon brings the global Medical Device community together to openly discuss the most pressing issues facing the industry. You have the opportunity to influence decisions and have your voice heard as you interact with leading FDA officials and field investigators, along with global industry experts at MedCon 2017 presented by Xavier Health.
Find out more »September 2017
2017 Xavier Combination Products Summit
Inspiring Collaboration… Feel the Purpose-Driven nature of this Summit as soon as you enter the room Expect orchestrated engagement with your peers across the industry on topics you are passionate about Find attendees openly sharing their expertise to help advance the industry in collaboration with regulators Work side-by-side with regulators to deepen the understanding on both sides of challenges and opportunities Leading Innovation… Identify solutions that will protect your patients around the world, your company brand, and your business Talk about…
Find out more »March 2018
2018 FDA/Xavier PharmaLink Conference
At PharmaLink, we work to find solutions that will increase confidence in your product quality throughout your global supply chain. We do this by aligning with the strategic priorities of the Food & Drug Administration. We help participants create links to drive new thinking. The solutions might not be evident within our industry, so we explore beyond our industry, beyond borders, and beyond comfort zones. Don’t miss this opportunity to join your colleagues and global regulators from around the world…
Find out more »Xavier Health: 2018 Data Integrity Master Class
Join Xavier Health the day before the FDA/Xavier PharmaLink conference, for the Data Integrity Master Class, Tuesday, March 13, 2018, from 8am-4pm, at Xavier University. John Avellanet, who trains the FDA on how to find data integrity issues in companies worldwide, will provide answers, examples and steps to take today to reduce your risk to your company products and patient. Arrive at 7:30am and enjoy a complimentary warm breakfast before the class starts. Register today for this very interactive class,…
Find out more »May 2018
Xavier Health: 2018 Case for Quality Workshop
Join Xavier Health the day before the FDA/Xavier MedCon conference, for the Case for Quality Workshop, Tuesday, May 1, 2018, from 11:30am-4pm EST, at Xavier University. In 2011, CDRH launched the Case for Quality initiative in an effort to shift the focus of industry and FDA from one of compliance and enforcement to one of quality ownership, based on the concept that a focus on quality ownership will improve product quality and patient safety, while naturally resulting in compliance. As…
Find out more »August 2018
Xavier Health AI Summit 2018
Join FDA and Industry Experts to Develop Quality, Regulatory, and Supply Chain Solutions Through the Power of AI. AI Realized. The Xavier Artificial Intelligence Initiative presents AI Summit 2018, August 23-24. Be a part of the future of our industry by: Understanding the current use of AI in the medical device and pharma industries Exploring cutting-edge possibilities of how the power of AI can be applied to solve your challenges in quality, regulatory, and supply chain Engaging in AI industry-wide…
Find out more »September 2018
Xavier Health Combination Products Summit 2018
Join Xavier Health for the Combination Products Summit on September 11-13. Collaborate with experts. Walk away with solutions in-hand. Experience the Xavier Difference at CPS: Interact with FDA and industry experts. Network with your colleagues and share challenges. Accelerate your product approval by learning about new streamlined FDA processes. Work through an advanced case study and participate in deep dive sessions with the experts. Create action plans to implement right away. Register now for Combination Products Summit 2018, happening September…
Find out more »March 2019
FDA/Xavier PharmaLink 2019
Join Xavier Health to engage in rich discussion with FDA and industry leaders so you can walk away with solutions to your toughest challenges! Register now for FDA/Xavier PharmaLink Conference, March 12-15, 2019. PharmaLink 2019 Agenda Highlights Engage in paradigm-shifting dialog that leads to practical supply chain solutions you can implement today, such as: FDA Quality Metrics Program: FDA Gemba Journey with Industry through Feedback and Site Visit Options. MHRA Strategic Priorities and Trends that Impact You Every Day FDA…
Find out more »Xavier Health EU MDR Workshop 2019
Join BioOhio partner Xavier Health for the EU MDR Workshop in Cincinnati March 27-28, 2019. Experts Bassil Akra (TÜV SÜD), Philippe Auclair (Abbott), Gert Bos (Qserve), and Kim Trautman (NSF), will lead you through the development of a time-critical action plan for keeping your medical devices on the EU market using proven strategies and tactics. At this workshop, you will develop advanced strategies to effectively work with notified bodies; insightful game plans for compiling the data required to certify your products;…
Find out more »April 2019
FDA/Xavier MedCon 2019
The FDA/Xavier University Medical Device Conference, MedCon, is a conference with formal FDA partnership that engages medical device manufacturers in discussion on how to increase the consistency and reliability of product quality while complying with FDA regulations. MedCon includes Data Integrity Master Class, Breakthrough Supply Chain Performance Workshop, and conference sessions. Click here to learn more and register.
Find out more »Xavier Health Breakthrough Supply Chain Performance
Join Xavier Health before the FDA/Xavier MedCon conference sessions for the advanced workshop, Breakthrough Supply Chain Performance, facilitated by authors of the newly-released Good Supply Practices for the 21st Century, including Marla Phillips (Xavier University), Tuesday, April 30, 2019, from 8am-4pm, at Xavier University. Through a key paradigm shift discovered by a team of FDA and industry team members, the Good Supply Practices (GSPs) attack the true root cause of the supply chain failures your organization has experienced! You now have the power…
Find out more »Xavier Health Data Integrity Master Class
Has your company implemented the newly-released FDA Data Integrity Guidance? Learn what you need to do by participating in the Xavier Health Data Integrity Master Class, Tuesday, April 30, 2019, from 8am-4pm, at Xavier University. John Avellanet, who has trained regulatory agency officials on advanced inspection tactics for data integrity, will provide the latest information, answers, examples, and steps to take today to reduce risk to your products and patients. Arrive at 7:30am and enjoy a complimentary warm breakfast before…
Find out more »August 2019
Xavier Health AI Summit 2019
Join BioOhio partner Xavier Health for the 2019 AI Summit in Cincinnati August 20-22, 2019. Be a part of the future of our industry by understanding the current use of AI in the medical device and pharma industries; exploring cutting-edge possibilities of how the power of AI can be applied to solve your challenges in quality, regulatory, and supply chain; engaging in AI industry-wide solution discussion sessions; and joining an AI Solution Team during the summit and beyond. Click here…
Find out more »September 2019
Xavier Health Combination Products Summit 2019
Join BioOhio partner Xavier Health for the Combination Products Summit in Cincinnati September 11-13, 2019. Experience the Xavier Difference by interacting with FDA and industry experts; networking with your colleagues and sharing challenges; accelerating your product approval by learning about new streamlined FDA processes; working through an advanced case study and participating in deep dive sessions with the experts; and creating action plans to implement right away. Click here to learn more and register.
Find out more »March 2020
FDA/Xavier PharmaLink Conference
Join Xavier Health to engage in rich discussion with FDA and industry leaders so you can walk away with solutions to your toughest challenges! Save the date for the FDA/Xavier PharmaLink Conference on March 17-20, 2020.
Find out more »