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.

23andMe Plans to Invent its Own Drugs

23andMe, a DNA analysis service company who provides information and tools to individuals to learn more about their DNA has announced its plan to invent its own drugs using customer data. This drastic move will allow 23andMe to capitalize on the economic value its genetic databases can create. The company’s robust database has provided genetic information of great value to Pfizer and Genentech, two of the Big Pharma companies.

By focusing on the customer first and foremost, 23andMe plans to develop a new drug that will provide an excellent benefit to its customers. 23andMe, the company that was providing valuable genetic information to two Big Pharma companies may be one of its greatest competitors in the coming years.

Click here to read Matthew Herper’s full article on Forbes.

FDA requires additional label warnings on multi-dose diabetes pens

To reduce the serious risk of spreading infections and ensure insulin pens and other injectable diabetes medicines are being used appropriately, FDA is mandating these injectable devices display the warning label “For single patient use only.”  Multi-dose pen devices are designed to be administered to a single patient multiple times, not multiple patients. The sharing of these devices amongst multiple patients significantly increases the risk of infection spreading. Over the last seven years, thousands of patients have potentially been victims to infections transmitted through the sharing of these multi-dose injectable devices. The “For single patient use only” warning label is intended to greatly reduce the risk of spreading infection amongst patients.

Click here to read FDA’s full safety announcement.

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!

European Medicines Agency (EMA) to go Paperless for its Application Forms

The EMA plans to reduce the administrative headache by ditching the paper and going digital as part of the major effort to transition to international and electronic standards in the European Union. For all applications using the centralized procedure, companies will be required to use electronic application forms beginning July 1st, 2015. The EMA states moving to the new application forms will remove the manual data extraction processes, provide higher data quality due to more structured state entry, and bring the industry toward a single application process among other benefits.

To read Michael Mezher’s full article, click here.

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!

Upcoming Second Annual BSI Mini-Roadshow Event on April 16th in Chicago

BSI logoThe British Standards Institution (BSI), the world’s first national standards body to partner with medical device manufacturers is holding its second annual Mini-Roadshow program on April 16th. The event topics include:

  • European Regulatory Update – CE, 13485, OBL
  • Clinical Data Evaluation – Lesson’s Learned
  • Compliance Navigator & Action Manager
  • Technical Files – Key Pitfalls
  • UAV & MDSAP Update

Presenters: Paul Brooks, Ibim Tariah, and John Bis

What: BSI Medical Device Mini-Roadshow

Where: Chicago Marriott Naperville1801 North Naper Boulevard Naperville, IL 60563

When: April 16th, 2015 from 8:30AM – 12:30PM

 

Registration is FREE! To register and learn more, click here.

We hope to see you there on April 16th!