Regulatory 101 workshop for medical device industry will feature Gretchen Bowker, co-founder & COO of Pearl IRB

IMDMC regulatory 101 workshop REG 101 indy life science eventThe Indiana Medical Device Manufacturers Council (IMDMC) is hosting a workshop on May 17, 2017 designed to provide someone new to the medical device industry a background in FDA regulation and to hone the skills of more experienced practitioners. This program has been developed to provide practical examples and regulatory information through interactive teaching methods, from experts in each field. Attendees will take a hypothetical device from pathways to market, through clinical trials, promotion and advertising. Participants will then work through recalls, QSR & MDR reporting and inspections, while addressing other areas of regulation along the way.

Pearl IRB COO and co-founder, Gretchen Bowker RAC, FRAPS, will present during REG 101, which is Day 1 of the two-day workshop. REG 102 will occur the following week on May 24.

What: A workshop exploring FDA regulations of medical devices and pathways to market.

When: Wednesday, May 17, 2017, 8:00 AM to 5:00 PM EDT (REG 101) and

Wednesday, May 24, 2017 8:00 AM to 5:00 PM EDT (REG 102)

Where: The Montage – 8580 Allison Pointe Boulevard, Indianapolis, IN 46250

Are you new to the medical device industry? Do you want to learn more about the FDA and the Pathways to Market? Register here today for one of the classes or register for both at a reduced price!

Day 1 Agenda 5/17/17 (8:00 AM – 5:00 PM)

  • Breakfast is 7:30 – 8:00
  • FDA Overview & intro to Hypothetical
  • Clinical Trials/IDE’s
  • Pathways to Market 510K Requirements
  • Pathways to Market PMA Requirements
  • Other Submissions & Special Issues
  • Pre-Market QSR
  • Labeling, Advertising & Promotion
  • Panel Discussion “Linking the Pieces” and Q&A

Day 2 Agenda 5/24/17 (8:00 AM – 5:00 PM)

  • Breakfast is 7:30 – 8:00
  • Review of Hypothetical
  • Post-Market QSR
  • Complaint Handling/Medical Device Reporting
  • Sales & Marketing: Regulatory Aspects
  • Recalls and Field Corrections
  • Inspections
  • Other Liability Mechanisms
  • Enforcement
  • Panel Discussion “Linking the Pieces” and Q&A

Registration closes this week. Register today to learn from medical device industry experts and network with your peers!

Save the date, November 18th – Indiana Life Sciences Collaboration Conference Series event

life sciencesPearl Pathways is a proud sponsor of the Indiana Life Sciences Collaboration Conference Series presented by the Kelley School Center for the Business of Life Sciences.  Please join us for the November 18th conference – Indiana’s Life Sciences Ecosystem – The Last 10 Years and the Next 10.  The event will be held at the IU School of Medicine, Fairbanks Hall, in Indianapolis.  This event proves to be an excellent forum that brings together key players in Indiana’s life science and healthcare arenas.  An intriguing look back at the change that has occurred in life science organizations in the last 10 years, excellent discussions and networking make this event one to attend.  Register today and learn more about the Indiana Life Sciences Collaboration Conference here.

Save the date: 2nd Annual Cell Therapy and Regenerative Medicine Symposium held in Indianapolis 6/13

Pearl Pathways will again be sponsoring the 2nd Annual Cell Therapy and Regenerative Medicine Symposium to be held June 13, 2016 in Indianapolis, Indiana. The theme is commercialization and the title of this year’s program is “Commercialization and Health Care System Engagement in Regenerative Medicine: Disruptive Solutions for Unmet Medical Needs”

This two day event will include sessions on Day 1 and an opportunity to register for individual regulatory consultations on Day 2. Attendees are also invited to submit abstracts which will be presented at a poster session.

Gretchen Bowker, COO of Pearl Pathways will be attending and offering 1-1 consulting sessions with researchers on Day 2.

What: Commercialization and Health Care System Engagement in Regenerative Medicine: Disruptive Solutions for Unmet Medical Needs

Where: The Athenaeum 401 E. Michigan Street Indianapolis, IN 46202

When: June 13 – 14, 2016: See agenda for session times

Register for the event:  Click here

May 13th, Pearl Pathways sponsors Indiana Life Sciences Collaboration Conference Series at Cook Medical World Headquarters

life sciencesPearl Pathways continues to be a proud sponsor of the 2015-2016 Indiana Life Sciences Collaboration Conference Series, presented by the Kelley School’s Center for the Business of Life Sciences. This is an excellent forum bringing together key players in Indiana’s life science and healthcare arenas for intriguing business discussions on business strategy, solutions and development to promote growth.

Diana Caldwell, President and CEO of Pearl Pathways, shares that “The conferences add value for all of the major life science players in the state. It’s a great means to get us together, hear relevant topics from thought leaders, stay up to date, and network.”

Please joins us for the May conference — The Shift from In-patient to Alternate Care Settings to listen to stakeholder perspectives on how companies, providers and payers are seeing and responding to technology advances, cost pressures, and patient visits and treatments moving out of traditional hospital settings.

What:          The Shift from In-patient to Alternate Care Settings

Where:       Cook Medical World Headquarters 750 Daniels Way, Bloomington, IN

When:         May 13, 2016

Please click here to register for the May conference. You may learn more about the Indiana Life Sciences Collaboration Conference Series at this link.

Join in Upcoming Life Sciences Lunch Series, February 16th with Diana Caldwell as panelist

The Indiana Health Industry Forum (IHIF) and Barnes & Thornburg present “Clinical Trials from a Study Site Perspective” featuring Pearl Pathways’ own President and CEO, Diana Caldwell as a panelist. This presentation and luncheon will be held on February 16th at the Barnes & Thornburg office at 11 S. Meridian Street in downtown Indianapolis, 11:30 – 1:00pm. Learn more and register today.

Upcoming Event: DA4S conference in Long Beach, CA February 17 – 18, 2016

DA4S Logo

The Diversity Alliance for Science (DA4S) conference will be held at the Marriott Long Beach Airport Hotel, in Long Beach, CA on February 17-18, 2016. DA4S is a non-profit organization focused on supporting, developing, and connecting with a diverse group of suppliers in the Life Science, Pharmaceutical, Bio-Tech, and Healthcare Industries. To register, please click here. Find out more about DA4S here.

Pearl Pathways is proud to sponsor Indiana Life Sciences Collaboration Conference Series

life sciences

Pearl Pathways continues to be a proud sponsor of the 2015-2016 Indiana Life Sciences Collaboration Conference Series, presented by the Kelley School’s Center for the Business of Life Sciences. This is an excellent forum bringing together key players in Indiana’s life science and healthcare arenas for intriguing business discussions on business strategy, solutions and development to promote growth.

Diana Caldwell, President and CEO of Pearl Pathways, shares that “The conferences add value for all of the major life science players in the state. It’s a great means to get us together, hear relevant topics from thought leaders, stay up to date, and network.”

Please joins us for the first conference of the year — The Continuing Disruption of Healthcare and Life Sciences Business Models for panel discussions on Changes in Healthcare and Medical Products “Space” and The Future of Medical Products in an Era of Reform: Implications of Value and Consumerism.

What:          The Continuing Disruption of Healthcare and Life Sciences Business Model

Where:       One America Tower, One American Square, Indianapolis

When:         February 19, 2016

Start 2016 with this on your calendar, please register here. To find out more about the Indiana Life Sciences Collaboration Conference Series, see this link.

 

Save the Date: IHIF 2016 Legislative Breakfast Briefing

The Indiana Health Industry Forum (IHIF) will host the annual Legislative Breakfast Briefing on January 27, 2016.  The event will be held at the Downtown Indianapolis Hilton Hotel.  This briefing provides education on Federal and State public policy issues and activities.  For more information, click here.

Indiana Life Sciences Collaboration Conference Series Upcoming Event on May 8

life sciencesAs a sponsor of the 2014-2015 Indiana Life Sciences Collaboration Conference Series, Pearl Pathways would like to announce the upcoming conference entitled The Changing Role of the Consumer in Healthcare. We invite you to join us at the event on Friday, May 8, where a panel of experienced industry professionals will discuss the responsibility in the healthcare industry shifting more and more to the consumers/patients. Providers are becoming less prescriptive and more of a partner to the consumer/patient due to the dynamics of the industry.

What: Discussion on the Changing Role of the Consumer in Healthcare

Where: Purdue Research Park, 1 Geddes Way, West Lafayette, IN 47906

When: May 8, 2015 8:00am-3:15pm

Register here for the event.

The Indiana Life Sciences Conference Series is presented by the Kelley School’s Center for the Business of Life Sciences. These conferences provide an opportunity for various industry professionals to discuss important business strategies and solutions to promote the advancement of the life sciences field. For additional information, click here.

We hope to see you there!

Indiana Life Sciences Collaboration Conference Series upcoming event on Mobile Healthcare

life sciencesAs a sponsor of the 2014-2015 Indiana Life Sciences Collaboration Conference Series, Pearl Pathways would like to announce the upcoming conference entitled Mobile Healthcare: Where Does New IT Intersect with Healthcare? We invite you to join us at the event on Friday, February 20th, where a panel of experienced industry professionals will discuss the potential effects of technology use, specifically the use of “smart phones” and new information technology intersects with healthcare.

 

What: Discussion on Mobile Healthcare and Where New IT Intersects with Healthcare

Where: IUPUI, Hine Hall (Formerly IUPUI Conference Center), 875 North Street, Indianapolis

When: February 20th, 2015 8:00am-3:15pm

Register Here!

The Indiana Life Sciences Conference Series is presented by the Kelley School’s Center for the Business of Life Sciences. These conferences provide an opportunity for various industry professionals to discuss important business strategies and solutions to promote the advancement of the life sciences field. To learn more, click here.

We hope to see you there!