Pearl Pathways sponsoring, attending Asia-Pacific Device Summit in San Diego

Pearl Pathways is excited to sponsor its Asia partner and attend upcoming Asia-Pacific Summit for Medical Devices, a two-day intensive seminar on medical device regulations. This conference provides an opportunity to network and hear first-hand accounts from several local experts from Asia-Pacific. Some of the topics include managing growth, ensuring sales, marketing, and regulatory compliance, and structuring for flexibility, compliance, and success. We invite you to join us at the event!

What: Asia-Pacific Device Summit

When: March 5th – 6th, 2015

Where: Hilton San Diego Mission Valley Hotel

Prices will go up in February, so register here today!

We hope to see you in San Diego!

New FDA Approach to Medical Device Accessory Regulation

FDA has released a draft guidance on its new approach for defining and classifying new medical device accessory types. Device accessories have previously been classified in congruence with the parent device or as a completely separate classification regulation. The new FDA approach intends to classify the risk of the device when used with the parent device, as intended. In theory, this will provide a more accurate risk classification for the accessory devices, thus assuring the safety and effectiveness of the device.

In order to get new medical device accessories to the market more promptly, the guidance suggests that manufacturers use the de novo classification process to classify new types of device accessories.

Need help mapping out the regulatory path for your medical device accessory? Contact us at contact@pearlpathway.com.

To read Alexander Gaffney’s full article on raps.org, click here.

Webinar on 8 tips for Asia Pacific regulatory success – February 5th

Do you find the market entry in Asia Pacific challenging? Pearl Pathways’ Asia partner, Brandwood Biomedical will be hosting a webinar highlighting common traps and tips for regulatory success in the challenging Asia Pacific market.

What: Live webinar exploring the 8 tips for Asia Pacific regulatory success

When: Thursday, February 5th, 2015 12:00PM – 12:30PM EST

Follow the link and register here today!

All participants in the webinar will receive a 5% discount to the Asia Pacific Devices Summit on March 5th-6th, 2015 in San Diego.  For additional details about the summit, click here.

FDA releases draft guidance to help reduce driving impairment

FDA has kept a close eye on psychoactive drugs—especially sleep aids—with concerns that many patients have experienced side effects well after the drug should have worn off, ultimately impairing their ability to safely perform activities such as driving, and causing accidents. After issuing numerous warnings, FDA has released a new draft guidance entitled Evaluating Drug Effects on the Ability to Operate a Motor Vehicle.

The guidance provides recommendations for all psychoactive drug manufacturers to assess their products’ impact on driving ability and demonstrate safety. FDA has also recommended “driving studies” with a “tiered” approach to properly evaluate the drug’s effect on a patient’s ability to operate a vehicle. The following categories have been provided to measure drug effects:

  • Alertness/arousal/wakefulness
  • Attention and processing speed
  • Reaction time/psychomotor functions
  • Sensory-perceptual functioning
  • Executive functions

The guidance provides additional information on how to conduct driving studies and urges pharma companies to review any data regarding their drug’s impact on a patient’s ability to drive.

To read FDA’s draft guidance, click here. For additional information, click here to read Alexander Gaffney’s article from RAPS.org.

Pearl Pathways is attending DA4S – West Coast

Diversity Alliance for Science (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. Our President and CEO will be attending the DA4S West Coast Event this year. Let us know if you plan on attending.

What: Diversity Alliance for Science’s 3rd Annual West Coast Event

Where: Hilton San Diego Resort & Spa, San Diego, CA

When: February 18-19th, 2015

There are not many seats left, so click here to register today!

View full website to learn more about Diversity Alliance for Science.

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.

FDA announces medical device guidance documents to be released in 2015

The FDA’s Center for Devices and Radiological Health has recently released a list of all medical device guidance documents it plans to release in 2015.  The list, also known as the “Guidance Agenda,” outlines the federal laws and regulations that are planned to be enforced and published by FDA this year. The list is prioritized and divided into two lists, an “A-List” and a “B-List,” with the “A-List” taking precedence.

The list is comprised of 28 device guidance documents including software and diagnostics. Top priority documents are related to regulating lab-developed tests (LDTs) and speeding up device submissions.

For more information, read Alexander Gaffney’s article from raps.com. To view the Guidance Agenda on FDA’s website, click here.

Upcoming Indiana Life Sciences Collaboration Conference Series Event

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 and ever-growing effects of technology use, specifically the use of “smart phones” and new information technology intersects with healthcare.

What: A 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

Click here for the registration link.

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.

FDA announces requirements for compounding pharmacies

According to a recent announcement, FDA will require large compounding pharmacies to register annually, pay a $15,000 annual fee, and report a list of all manufactured products every six months. These requirements were established in three guidance documents, explaining how to comply with the regulations for outsourcing facilities.

A few key takeaways from the guidances include:

  • Compounders may withdraw their registration
  • Any registered compounder must re-register each year between October 31 and December 31
  • All outsourcing facilities must register and submit product reports through FDA’s electronic submission process. Email submissions will no longer be accepted.

FDA estimates at least 1,000 U.S. large compounders are eligible for registration; 51 have registered so far.

For more information, read Robert King’s article from FDAnews.com here.

Pearl Pathways announces global partnership with Brandwood Biomedical

Pearl Pathways is pleased to announce a partnership with Brandwood Biomedical, an Australia-headquartered regulatory and quality services company with offices throughout Asia. This collaboration allows both companies to provide on-the-ground support to clients and better adapt to the changes and complexities associated with global markets. For more information, read our full press release here.

In addition, Pearl Pathways and Brandwood Biomedical will be hosting the The Asia-Pacific Summit for Medical Devices, a two-day intensive seminar on medical device regulations featuring a variety of local experts from Asia-Pacific.

When: March 5-6, 2015

Where: Hilton San Diego Mission Valley Hotel

Register here before December 5 to enjoy the lowest early bird pricing!

We hope to see you in San Diego!