FDA adopt guidelines from ICH

Alexander Gaffney from raps.org has just released an article on regulators releasing the latest guideline on electronically transmitting individual case safety reports (ICSR) from the International Conference on Harmonisation’s (ICH). ICH is a pharmaceutical harmonization group that is run by US FDA, European Medicine Agency (EMA), and Japan’s Ministry of Health, Labor and Welfare (MHLW). ICH aims to have regulatory processes better align with different administrations allowing for greater efficiency between industry and regulators. The final guideline, E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification, provides an outline for the data, terminology, and exchange standards for ICSR submissions to improve the quality of data and improve the analysis of the documents. To read the full article click here.

Setback for EMA’s vision of transparency

Raps.org journalist, Alexander Gaffney reported that an EU court has surprisingly issued an interim order that the European Medicines Agency (EMA) should stop publishing any more information or documents until a final order has been passed regarding public information. This is a setback for the EMA, whose goal is to make public all clinical and non-clinical data.  Proponents of data transparency include the people behind the AllTrials campaign, whom have the same goals as the EMA. Companies such as Abbvie and Intermune, leaders in drug and medicine innovation, have fought the idea of transparency. They have sued the EMA on grounds that the information publicized is “commercially confidential information”, in which the EU court agreed with.  EMA’s head of communication, Mark Harvey, commented on the situation via Twitter saying “disappointing, but not the end”. EMA will appeal the court’s ruling and continue with their battle to make all data and information publicly available. Is this the next step in clinical data? To read the full article click here.

Save the Date: February 25, 2013 RAPS Indiana Chapter networking event

Join Pearl Staff at the ‘Celebration of Life Sciences in Indiana Networking Reception’ hosted by the RAPS Indiana Chapter.  The focus of the event is to promote new connections among local regulatory professionals. A BioCrossroads representative will also provide an update about the life sciences in Indiana.

What: Celebration of Life Sciences in Indiana Networking Reception

When: February 25, 2013

Time: 4:30-6:30pm

Where: Faegre Baker Daniels LLP, 600 E. 96th Street Suite 600, Indianapolis, IN

Directions are available online or by calling +1 317 569 9600

Contact Cindy Killion at cynthia.killion@faegrebd.com to RSVP.

To learn more about RAPS Indiana, click here.

September 11, 2012–RAPS presents “The New FDA Landscape in Medical Device Development”

The RAPS Indiana Chapter presents the expert presentation, “The New FDA Landscape in Medical Device Development.”

Where: MED Institute Inc., West Lafayette, IN

When: September 11, 2012 from 5:15 – 8 p.m.

Cost: $40 for non-members and $25 for members

Stay current on FDA activities that are affecting device development and exchange ideas with other local regulatory professionals.

This interactive discussion will include a meal for all participants, and attendees may claim two RAC recertification points.

To register and learn more about this event, click here.

Tuesday, June 26th–RAPS presents expert presentation!

The Indiana chapter of RAPS presents an expert presentation entitled, “Steps to Preparing for a Successful FDA Advisory Committee Meeting!”

Pearl’s own Gretchen Bowker, RAC, FRAPS  is the Indiana RAPS Chapter Chair.

When: June 26, 2012 from 4 – 6:30 pm

Where: Indiana University Emerging Technology Center in Indianapolis, IN

Cost: $15 for members and $30 for non-members

There will be a light meal provided for all meeting participants and attendees may claim two RAC recertification points.

To register for this event, click here. For more information about this event, click here.

RAPS Indiana Chapter Event: May 14th, 2012

Please join us for a lively discussion directed by Jody Roth about “Key Regulatory Trends in 2011 Biological Approvals” at the next RAPS Indiana Chapter event.  The event will be held on May 14th, 2012 from 4:00pm-6:00pm at the IUETC Ice Miller Room.  To register, click here.

Don’t Miss the RAPS Indiana Chapter Meeting: February 21, 2012

Join us on February 21, 2012 from 4:00-6:00pm at the Indiana University Emerging Technology Center (IUETC) for a lively discussion. The topic of discussion is a review of 2011 FDA highlights and projections for 2012. The meeting will be led by our own Gretchen Bowker who is the Indiana Chapter Chairperson. This is a great opportunity to join your regulatory colleagues from the Indianapolis region to discuss the major points from 2011 and better prepare yourself for what lies ahead in 2012. Snacks will be provided! To register for the event, click here.

Gretchen Miller Bowker, Pearl’s COO, honored by RAPS on October 24, 2011

Gretchen Miller Bowker, Pearl’s COO was awarded a very special award today:  the RAPS (Regulatory Affairs Professionals Society) Fellow award. As thousands of regulatory compliance professionals converge in Indianapolis, Pearl Pathways’ COO was honored. Visit our Pearl Pathways website and click here to view full press release.

Gretchen Miller Bowker, MS, RAC – Chief Operating Officer and Co-Founder

Gretchen Miller Bowker, MS, RAC – Chief Operating Officer and Co-Founder

Check out September 14th IBJ article focused on RAPS conference and featuring Pearl IRB

On September 14th, IBJ ran a great article entitled “Health regulatory leaders ready to flock to city.” This is the first time RAPS has held its annual conference, and, as such, the first time Indianapolis has hosted so many regulatory scientists in the Circle City.   Gretchen Bowker, our COO is quoted as saying “The regulatory person is the mediator between the scientists and the government agency,” and is recognized as the Chair of the brand new RAPS Indiana Chapter.  Please stop by and see us in our booth or during Gretchen’s speaker session the week of October 23rd at the Convention Center in downtown Indianapolis.  To read the IBJ article, click here.   To learn more about the RAPS conference, visit their site at www.raps.org/2011raps.

RAPS Indiana Chapter inaugural kick off meeting on August 30, 2011

Please join us for the first RAPS (Regulatory Affairs Professional Society) Indiana chapter meeting on August 30th at 4pm to be held at the IUETC.  This will be an interactive meeting to prioritize the membership’s interests and needs for future programming.  And a drawing will be held to give away the conference registration fee for the upcoming October National RAPS meeting which this year is held in our own home town, Indianapolis.  Pearl’s COO, Gretchen Bowker is the new Chapter Chair.  To register and learn more, click here.

Hope to see you there!