FDA to release draft guidance on approving medical devices using foreign trial data

Set to release Tuesday, April 28, FDA plans to issue a draft guidance document regarding its current policy of accepting clinical trial data performed outside the United States in support of medical device premarket submissions.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.

Such 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

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

To learn more, read Outsourcing-Pharma’s article by Zachary Brennan.

Pearl Pathways’ own, Diana Caldwell, named Indiana’s Outstanding Achiever on behalf of CEED

Pearl Pathways is pleased to announce that its President and CEO, Diana Caldwell, has been honored as the Center for Empowerment & Economic Development’s (CEED) Indiana Outstanding Achiever this year. This award is granted by CEED to individuals or organizations that share the CEED vision and demonstrate the true qualities of leadership.

Caldwell shares, “To be associated with such an impressive group of women leaders, I am honored and humbled to be recognized as this year’s Indiana Outstanding Achiever award on behalf of CEED.”

All award honorees for 2015 will be recognized by CEED on Thursday, April 23, in Novi, Michigan at the 31st Annual Award Celebration. This award will also be presented to Caldwell at the Sheraton Indianapolis Hotel at Keystone Crossing on Tuesday, June 9, 2015 at a luncheon reception. To learn more about the celebration, click here.

Click here to read our full press release.

Pearl Pathways sponsoring, attending IVD Conference in San Diego

Q1 Prodcution LogoPearl Pathways is excited to sponsor Q1 Productions’ and attend its upcoming IVD conference on Clinical Affairs and Regulatory Approvals for Diagnostics. The conference provides an excellent opportunity to network with industry experts and gain additional insight on the FDA pathway for next generation sequencing, clinical and regulatory lessons learned in bringing a companion diagnostic to the market, and how to properly prepare for regulatory hurdles outside the United States. Pearl’s own Gretchen Bowker, Co-Founder and COO, will be presenting on ‘Interpreting and Applying FDA Draft Guidance’ at the event.

 

What: Q1 Productions’ 6th Semi-Annual IVD West Conference

When: May 4-5, 2015

Where: Hilton San Diego Harbor Island – 1960 Harbor Island Drive, San Diego, CA

Pearl Pathways is offering discounted tickets for the event. For more information or to arrange to join us at this event, please contact our Director of Business Development, Chad Pannucci at cpannucci@pearlpathways.com.

Click here to register today. We hope to see you in San Diego!

Updated fee schedule for Pearl IRB effective April 1, 2015

Please note that effective April 1, 2015, Pearl IRB has changed its fee schedule. See our 2015 Fee Schedule to view pricing for your upcoming study. For a price quote for Central IRB services, detailed pricing of your research project, or additional information about our services, please contact us at info@pearlirb.com.

Upcoming RAPS Midwest Regional Career Day on April 18th

RAPS LogoThe largest global organization for those involved with the regulation of healthcare and related products, Regulatory Affairs Professionals Society (RAPS), is holding its inaugural Midwest Region Regulatory Career Day on April 18th, 2015.

Are you looking for new career opportunities in the regulatory field? Do you plan to transition to regulatory affairs or are you looking for an opportunity to network with hiring representatives within the life science industry? If yes, this will be an advantageous event for you to attend!

What: RAPS Midwest Regional Career Day

When: Saturday, April 18th, 2015 from 10:00AM – 4:00PM

Where: Lambs Farm in Libertyville, IL

Prices will go up at the beginning of April, so register here today! For more information about the event, click here.

Pearl Pathways hires new Business Development Director, Chad Pannucci

Pearl Pathways is pleased to announce the hiring of Chad Pannucci as the new Business Development Director. Pannucci will be responsible for driving overall business development and sales of professional services within Pearl Pathways three business units including Pearl IRB, Pearl ReGXP, and Pearl IDEAS.

“Chad has a proven track record of driving business growth, launching new products and services, and influencing product development decisions in the fast changing medical device industry. His broad sales and product management skills will add value to our clients and help propel Pearl Pathways to the next level of growth,” shares President and CEO, Diana Caldwell.

Click here to read our full press release!

Upcoming IMDMC workshop on Inspection Readiness featuring Pearl Pathways’ own, Heidi Strunk

imdmcPearl Pathways’ own, Heidi Strunk, RAC will be presenting at the Indiana Medical Device Manufacturers Council (IMDMC) workshop in Indianapolis, Indiana entitled, A Deep Dive Into Inspection Preparedness. The workshop will provide an opportunity to hear from experts who will explore the FDA inspection process and offer tips on what you need to know and how to be prepared for an FDA inspection.

What: An exploration of all the perspectives of the FDA inspection process.

When: Wednesday, April 15th, 2015 8:30AM – 4:30PM EST

Where: Montage Banquet Center, Indianapolis, IN            

Are you ready for a FDA inspection? Do you want to learn more about the inspection process? To register for the workshop, click here! (Lunch will be provided.)

Click here to learn more about the workshop! We hope you join us on April 15th!

AAHRPP Accreditation further distinguishes the uniqueness of Pearl IRB

Pearl IRB becomes just the second AAHRPP accredited organization in the state of Indiana by demonstrating high standards of excellence for quality, ethics, and protection in all levels of research.

“We are extremely proud to have earned AAHRPP accreditation. Our clients want to work first and foremost with an IRB that demonstrates excellence, but many also have the business objective of engaging with diverse suppliers in the clinical research space. With Pearl IRB, they get both,” shares Pearl IRB’s President and CEO, Diana Caldwell.

Click here to read our full press release!

Gretchen Bowker will hold webinar on March 19th via ComplianceOnline

ComplianceOnline logoPearl Pathways’ own COO and Co-Founder, Gretchen Bowker will be holding a webinar on FDA regulatory requirements for the manufacturing and commercialization of dietary supplements via ComplianceOnline. A few of the topics include a review of FDA regulations in the area, history of Dietary Supplement Health and Education Act, and a review of applicable FDA guidance documents. For more information about the webinar, click here.

 

What: A Discussion on Nutraceuticals/Dietary Supplements and FDA Regulatory Submission and Manufacturing Quality Requirements

When: March 19th, 2015 1:00 PM EST

Where: ComplianceOnline

To register for the webinar, click here!

Do you plan to launch a product into this rapidly growing market? Are you responsible for the manufacturing or distribution of a dietary supplement, food drug, or nutraceutical? If yes, this is the webinar will be informative and valuable for you!

We hope you join us for the webinar!

Pearl IRB now accredited by AAHRPP

Pearl IRB is excited to announce its recent accreditation with the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Pearl IRB earned this distinction by demonstrating two primary techniques including extensive safeguards in all levels of the research operations and abiding by high standards for all research.

Pearl IRB is one of the four newly accredited organizations in the United States and one of only two AAHRPP accredited organizations in state of Indiana. Additionally, among the list of accredited organizations by AAHRPP include, The National Institutes of Health and Pfizer, Inc., the largest industry sponsor of clinical research.

Pearl IRB’s accreditation demonstrates its value in setting and following high standards for quality, ethics, and protection in all of its research.

Read full press release here!

Need support with your clinical research study?  Contact us at info@pearlirb.com.