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!

Experienced mechanical engineer and life science project manager joins Pearl Pathways

michele-taylorPearl Pathways is excited to announce the hiring of Michele Taylor as a regulatory compliance analyst. Taylor will help the Pearl team serve medical device and biopharmaceutical life science companies.

Taylor brings 12 years of experience in Project Management in Life Sciences, Medical Device Product Development, and Manufacturing to the Pearl Pathways team. Diana Caldwell, President and CEO shares, “Michele brings strong engineering and manufacturing background to the Pearl team. Our clients will benefit from her product development experience and incredible project management skills… We are thrilled to have her join the team.”

To read the full press release, please click here.

FDA Guidance on Adaptive Designs released

On July 27th, FDA released final guidance for Adaptive Designs for Medical Device Clinical Studies – a link to the guidance is here.  According to Zachary Brennan in his article posted on RAPS, FDA received 151 comments from industry and most were included in the final guidance.  The guidance explains that “An adaptive design for a medical device clinical study is defined as a clinical study design that allows for prospectively planned modifications based on accumulating study data without undermining the study’s integrity and validity.”  Examples are listed throughout the guidance to provide a better understanding of how to include this in your medical device clinical study planning.  Need help in planning your medical device clinical study?  Contact us here.

Register now for the Asia Pacific Device Summit

On March 10-11, 2016, the Asia Pacific Device Summit will be held in San Francisco, CA. This event will bring together medical device experts from Asia and the US. Click here for more information. Register for the event through Brandwood Biomedical, Pearl Pathways’ strategic international partner.

Come see Sarah Witwer teaching at Grace College

Sarah Witwer will be teaching for the third time in Orthopedic Regulatory and Clinical Affairs Program this fall at Grace College.

She has three decades of practice in the life science industry and is a Pearl Pathways Regulatory Compliance Advisor. Sarah is well seasoned in regulatory strategies, filings and more. Her course is called “RCA5500 Regulation of Medical Devices: Submission.” The class will be taught online, as well as two weekend of classroom time.

Are you interested in learning more about Sarah’s class? Click here to learn more.

FDA will release draft guidance on accepting clinical data performed outside the United States for medical devices

Set to release Tuesday, April 28, FDA plans to issue a draft guidance document regarding its current policy of accepting clinical trial data performed outside the United States in support of medical device premarket submissions. To be clear, this document is not intended to announce a new policy, but rather articulate specific measures and considerations that must be applied when using such data to ensure the foreign medical device clinical data is adequate under FDA standards.

Medical device manufacturers planning on submitting clinical data from outside the United States much provide the following information:

  • Detailed information about the research facilities and qualifications of the trial’s clinical investigators
  • Protocol and results summary
  • Full description of the device
  • Demonstration of the scientific validity for all of the gathered data
  • Ample assurances concerning informed consent

This guidance document could provide clarity, help ensure the data is compliant with FDA standards, and allow products to reach the global market sooner.

For more information, read Zachary Brennan’s article on Outsourcing-Pharma.

Pathways’ Bowker leads FDA supplier audit webinar

Are you a supplier of raw materials, component parts or finished product to biopharma or medical device companies? The supply chain for pharmaceuticals, biologics and medical device companies are increasingly being audited by their clients and FDA.  On July 25, 2013, Pearl Pathways’ own Gretchen Bowker will lead a webinar on FDA audits discussing the best practices and provide practical tips to prepare for FDA audits, as well as client audits. The webinar will be held through CompliaceOnline.com.

Where: ComplianceOnline.com: Register here.

Fee: $199.00

When: July 25, 2013

Duration: 60 minutes

For more information and registration click here.

Save the Date: March 27th, IMDMC Event

The legal implications of the Sunshine Law Final Rule will be discussed by a panel of experts at the March Indiana Medical Device Manufacturer’s Council (IMDMC) March event.

Topic:    Sunshine Law Final Rule: How to Ensure Compliance

When:   March 27, 2013

Where:  Montage Meeting Facility,8580 Allisonville Pointe Blvd, Indianapolis, IN 4625

Cost:     Members: $125        Nonmembers: $175

For more information and to register, click here.

First INpact meeting of 2013

Pearl staff is attending the first INpact lunch meeting of 2013 on Wednesday, January 23rd.   INpact is focused on supporting the medical device industry in Indiana. Please attend the lunch to network and learn more about the new bimonthly meeting format.

Time:  11:30-1pm

Date:  January 23, 2013

Where: Bingham Greenbaum Doll, LLP, 10 W. Market St., Suite 2700, Indianapolis, IN

Cost is $20 for non-members. To register, click here.

 

MWDG of the ASQ Biomedical Division meets October 25th: Human Factors in Medical Device Development

The Midwest Discussion Group of the ASQ Biomedical Division presents Human Factors in Medical Device Development on Thursday, October 25, 2012. Jim Kershner from Eli Lilly will share his experience dealing with issues around human factors in medical device development. Kershner will also share his widespread knowledge and hands-on experience on human factors investigations. The session will be held at the University of Indianapolis. Hot buffet, beverage and dessert will be served at this event.

When: Thursday, October 25, 2012

Where: University of Indianapolis, Schwitzer Student Center Building #7 Room #013 (on lower level)

Time: 5:30p.m. – 8:00p.m.

Cost: $12.50 for members, $15.00 for non-members

For full details of this event, click here.