Loading Events

Past Events › Regulatory & Reimbursement

Events Search and Views Navigation

Find Events

Event Views Navigation

Events Search

January 2019

R&Q Webinar: EU MDR: How do I interpret the new regulations and what do I need to do to be compliant?

January 16 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

BioOhio member R&Q is teaming up with Greenlight Guru for a webinar you won't want to miss on January 16th at 1pm ET! In May of 2017 the European Union’s Medical Device Regulation came into force and with that came a three year transition time which ends on May 26th, 2020. But despite the fact that we’re over 50% of the way through the transition, there continues to be anxiety and confusion surrounding how to interpret the EU MDR, what it means to…

Find out more »

NAMSA Webinar: Understanding and Applying ISO 19227 Requirements for Orthopedics Manufacturers

January 17 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA For the webinar Understanding and Applying ISO 19227 Requirements for Orthopedics Manufacturers on January 17 at 10AM. Published in 2018, new medical device standard ISO 19227 builds upon previous French Standard NF S94-091 for orthopedics manufacturers. It not only provides guidelines in parallel to ISO 10993 for biological safety, but also further standardizes approaches for orthopedic implant cleaning. This NAMSA webinar, presented by Nicola Revellin, PhD (Sr. Medical Research Scientist—EU Biological Safety & Validation), will explore the impact…

Find out more »

RAPS Ohio Networking Event: New Developments in the Premarket Notification Process

January 25 @ 5:30 pm - 8:00 pm
Cleveland State University – Washkewicz Hall, 2300 Chester Ave., Room 405
Cleveland, OH 44115 United States
+ Google Map

Join the RAPS Ohio Local Networking Group for a networking event featuring insightful discussion on the premarket notification process. This is a free event. Speaker: Anthony Piotrkowski, RAC, CQA – Director of Regulatory Affairs at STERIS Corporation Presentation Title: New Developments in the Premarket Notification Process The event will be held on the campus of Cleveland State University (CSU) in Washkewicz Hall.

Find out more »

February 2019

Intertek Webinar: Sustainability Solutions for Electrical Products

February 5 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member Intertek for the webinar Sustainability Solutions for Electrical Products on February 5 at 11am. The demand is intensifying for services that extend beyond quality and compliance, to those that deliver sustainable solutions for the future. This webinar discusses global sustainability trends that shape the electrical equipment industry. From design concept to End-of-Life (EOL) management, our sustainability experts will discuss the latest solutions and how they will impact your business. Attendees will gain a better understanding of methods to…

Find out more »

2019 BIO CEO & Investor Conference

February 11 - February 12
New York Marriott Marquis, 1535 Broadway
New York, NY 10036 United States
+ Google Map

Now in its 21st year, the BIO CEO & Investor Conference is one of the largest investor conferences focused on established and emerging publicly traded and select private biotech companies. Because our mission is to support industry-wide success, we present a broad and unbiased view of investment opportunities. Each year the BIO CEO & Investor Conference provides a neutral forum where institutional investors, industry analysts, and senior biotechnology executives have the opportunity to shape the future investment landscape of the biotechnology industry.…

Find out more »

NAMSA Webinar: Understanding Medical Device Reimbursement Fundamentals to Achieve Commercialization

February 20 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for the webinar Understanding Medical Device Reimbursement Fundamentals to Achieve Commercialization on February 20 at 11am EST. Most medical technology entrepreneurs will tell you that in recent years, reimbursement has become as large of a barrier to successful commercialization as regulatory clearance. Medical device manufacturers that do not plan early for reimbursement risk prolonged delays in bringing products to the market as the FDA approval/clearance process is an extremely important, single, sentinel event. In order to maximize…

Find out more »

RAPS Ohio Local Networking Group Event: EU Medical Device Regulation (MDR)

February 22 @ 5:30 pm - 8:00 pm
Case Western Reserve University, 10900 Euclid Ave
Cleveland, OH 44106 United States
+ Google Map

Join the RAPS Ohio Local Networking Group for a networking event featuring insightful discussion on EU Medical Device Regulation (MDR). This is a free event. Presentation Title: EU Medical Device Regulation (MDR) After almost a decade of development and negotiation, new regulations will help advances in medical device technology and include: Reclassification of some technologies and the inclusion of others that were previously exempted from regulation, as well as classification of software Increase in the oversight of the medical device…

Find out more »

R&Q Webinar: What is sufficient clinical evidence to meet the EU MDR?

February 26 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for the webinar What is sufficient clinical evidence to meet the EU MDR? on February 26 at 1 pm. The EU MDR lays out requirements for a proactive post-market surveillance system that inputs into the ongoing risk management and clinical evaluation processes throughout the device lifecycle. This session will address the expectations for sufficient clinical evidence and the opportunities, risks, and challenges associated with each. Additionally, we’ll cover requirements for PMS planning and PMS reporting for all…

Find out more »

March 2019

WDSrx Ribbon-Cutting Celebration – Lockbourne OH

March 6 @ 10:00 am - 11:00 am
WDSrx, 5653 Creekside Parkway
Lockbourne, OH 43137 United States
+ Google Map

Celebrate the expansion into Ohio of the pharmaceutical logistics services firm, and BioOhio member, WDSrx at a ribbon-cutting at their newest facility located in Lockbourne in beautiful Franklin County. WDSrx, Woodfield Distribution LLC, provides integrated third party logistics pharmaceutical services and value-added solutions empowering the Life Sciences industry. Supply chain operations include Warehousing, Storage, Fulfillment, Transportation Management, Temperature Regulated Environments, Reverse Logistics and Regulatory Compliant Product Disposition. Value-added solutions include on-site Packaging and Labeling, Clinical Trial Support, Customer Service, Patient Assistance Programs,…

Find out more »

GlobalReach: Exporting Chemicals and Hazardous Materials

March 7 @ 8:30 am - 2:00 pm
Austen BioInnovation Institute in Akron, 47 North Main Street
Akron, OH 44308 United States
+ Google Map

Join BioOhio leadership member Cleveland State University for GlobalReach: Exporting Chemicals and Hazardous Materials on March 7 at 8:30 am. Do you export chemicals, polymers, or other hazardous materials? Are you a prospective exporter of these products? Have you thought about tackling a new foreign market but are getting bogged down by regulatory hurdles and ambiguity? Do you struggle to maintain compliance with material safety data sheets? If any of this rings true for you and your company, you will not…

Find out more »

2019 Molecular Medicine Tri-Conference

March 10 - March 15
Moscone Center, 747 Howard Street
San Francisco, CA 94103 United States
+ Google Map

Join over 3,700 drug discovery, development & diagnostics professionals worldwide at the 26th International Molecular Medicine Tri-Conference! Since its debut in 1993, the annual Molecular Medicine Tri-Conference has become one of the world's leading international events in the field of drug discovery, development and diagnostics. The Tri-Conference unites an ecosystem of 3,700 innovative thinkers and thought leaders throughout biotech, pharma and academia from around the world. Spanning five days, the 2019 Tri-Conference includes compelling talks, including case studies and joint…

Find out more »

2019 Bio-IT World West Conference & Expo

March 10 - March 15
Moscone Center, 747 Howard Street
San Francisco, CA 94103 United States
+ Google Map

Bio-IT World Conference & Expo has established itself as a premier event showcasing the myriad IT and informatics applications and enabling technologies that drive biomedical research, drug discovery & development, and clinical and healthcare initiatives ... and now the Bio-IT World Expo is on the West Coast! Join us for compelling talks, including best practice case studies and joint partner presentations, from your fellow industry and academic colleagues discussing themes of big data, smart data, cloud computing, trends in IT…

Find out more »

FDA/Xavier PharmaLink 2019

March 12 - March 15
Cintas Center at Xavier University, 1624 Herald Ave.
Cincinnati, OH 45207 United States
+ Google Map

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 »

2019 MDMA FDA Forum

March 14 - March 15
Crowne Plaza Cabana Hotel, 4290 El Camino Real
Palo Alto, CA 94306 United States
+ Google Map

Join us at MDMA’s popular TWO day FDA Forum on March 14-15, 2019 in Palo Alto, CA. MDMA’s FDA Forum focuses on unique insights and strategies to govern the 510(k) and PMA regulatory pathways, as well as FDA reform efforts and more. This forum offers numerous interactive panels led by FDA officials, industry leaders and policy experts. Click here to learn more and register. BioOhio members are eligible for a $100 discount off the registration. Contact lreitz@bioohio.com to learn more.

Find out more »

NAMSA Webinar: Design Control: Understanding the Benefits of Starting Early and Why it’s Necessary

March 20 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on Design Control: Understanding the Benefits of Starting Early and Why it's Necessary on March 20 at 11 am. While design control has been a quality system requirement since 1996, many medical device organizations struggle to understand these requirements, as well as when to start the process and how to maximize the benefits of the system. For example, it is often mistaken that a design control process must be complex to meet the regulatory requirements and to ensure delivery of a…

Find out more »

R&Q Webinar: Biocompatibility: EU MDR and the changing regulatory landscape

March 26 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on Biocompatibility on March 26 at 1pm EST. This webinar will dive into the increased specificity of the EU MDR from a biocompatibility perspective and how the revised 10993-1 fits into the new requirements. We will share our experiences from the viewpoint of testing laboratory experts and regulatory consultants with biocompatibility experience from both science and regulatory affairs backgrounds. Our goal is to help you understand the changing regulatory landscape in light of…

Find out more »

Xavier Health EU MDR Workshop 2019

March 27 - March 28
Cintas Center at Xavier University, 1624 Herald Ave.
Cincinnati, OH 45207 United States
+ Google Map

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

PDA Chapter Networking at the Sapphire Creek Winery

April 11 @ 6:00 pm - 9:00 pm
Sapphire Creek Winery, 16965 Park Circle Drive
Chagrin Falls, OH 44023 United States
+ Google Map

Come join The PDA Midwest Chapter for a very casual networking event at the Sapphire Creek Winery in Northeast Ohio. Everyone at all stages of their career are welcome so bring your friends and colleagues. Although this is a free event, registration is needed to provide an accurate participation count for the venue. All are welcome to have a good time and to mingle with other professionals from across the Midwest in the bio/pharmaceutical industry. This is a wonderful opportunity…

Find out more »

Bio-IT World 2019

April 16 - April 18
Seaport World Trade Center, 200 Seaport Boulevard
Boston, MA 02210 United States
+ Google Map

The Bio-IT space right now is rife with hype. Blockchain, AI, machine learning, data science, deep learning, edge, IoT, and more are being touted as panaceas, sure to at least facilitate a cure for what ails you. There are some legitimately cool technologies maturing in our space, but there is also plenty of smoke and mirrors designed to conceal the tech growing pains. At Bio-IT World we strive to clear the air with in-depth technical presentations in 18 tracks, education…

Find out more »

R&Q Webinar: EU MDR for Combination Products

April 23 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q on Tuesday, April 23 at 1pm ET for this month's free webinar: EU MDR for Combination Products. Fresh off of their recent Advanced EU MDR and CER Workshops in Minneapolis and Boston, R&Q's Director of Regulatory Affairs Nancy Morrison will be presenting. The rules have changed with Article 117 and more companies will require notified body involvement. This is the first time devices integral to a drug product will require notified body assessment. Although the requirements…

Find out more »
+ Export Events