RAPS seeking nominations for 2018-2020 Board of Directors

raps indianaRegulatory Affairs Professionals Society (RAPS) is seeking qualified individuals to serve on the RAPS board of directors for the 2018-2020 term. RAPS, the largest global organization of and for those involved with the regulation of healthcare and related products (e.g. medical devices, pharmaceuticals, biologics, and nutritional products). Board members serve as the strategic governing and policy body of RAPS and identify opportunities that advance the profession and improve/expand association programs that support the profession globally.

2018-2020 Board Position Openings:

  • President-Elect (one open position)
  • Directors (four open positions)

Learn more about the nomination process and open positions here

Gretchen Bowker, COO and co-founder of Pearl IRB, currently serves as the chair of the RAPS Indiana Chapter. Bowker states that the “RAPS Indiana Chapter conducts a number of professional development and networking activities throughout the year to help members connect, build relationships, and increase knowledge, competence, and performance… RAPS is a volunteer-driven organization and I’ve found that the more I put into it, the more I get back.”

Interested in joining RAPS? Find your local chapter here and learn how to get involved today!

Save the date: RAPS Indiana Chapter hosts a senior FDA representative to speak about drug safety lifecycle management

raps indianaOn March 9th, the RAPS Indiana Chapter, chaired by Pearl Pathways COO Gretchen Bowker, will host an interactive presentation from a senior FDA representative. The FDA representative, Jill R. Bourdage, RPh, PMP, will speak about processes and procedures of the Office of Surveillance and Epidemiology (OSE) within the Center of Drug Evaluation and Research (CDER). The presentation will provide an overview of the OSE and its role in the continuum of drug safety lifecycle management. Anticipated updates from PDUVA VI will be covered and the audience will learn how the role of the OSE Safety Regulatory Project Manager and regulatory expert as point of contact for industry can help achieve optimal communication.

Presentation title: Optimizing Communications with the Office of Surveillance & Epidemiology

Date: March 9, 2017

Time: 5:30 – 8:00pm EST

Location: Purdue University: Seng Liang Wang Hall

West Lafayette, IN

Registration and more information about the content can be found here.

Purdue professor to host free webinar for RAPS members: Emerging Issues in Manufacturing with Impact on Quality

raps indianaOn Thursday, November 17th, Purdue University’s professor of Medicinal Chemistry, Dr. Stephen R Byrn, will host a free webinar exclusive for members of the Indiana Regulatory Affairs Professionals Society (RAPS) Chapter. Members may register for the webinar here.

Join in to learn at the RAPS Indiana Chapter meeting on June 16th

raps indiana“Practices and Preferences of CDRH Advisory Committee Members – Know Your Audience” is the topic of an upcoming presentation by Susan Resnick, PhD of 3D Communications. The RAPS Indiana Chapter, chaired by Pearl Pathways’ COO & RAC, FRAPS, Gretchen Bowker, is hosting this evening of networking and presentation for regulatory professionals. The event will be held June 16th, from 6:00pm-8:30pm at The Rathskellar Restaurant, Indianapolis. To get the latest understanding of practices and preferences of advisory committee members and how to prepare for panel meetings, don’t miss the presentation – click here for more details! Register today.  You can also register by calling +1 301 770 2920 ext. 200. We encourage you to attend this special event!

Indiana Chapter of RAPS’ is hosting an event June 23rd

logoThe Regulatory Affairs Professional Society is hosting an event featuring Paul Brooks, Senior VP of BSI. The event is June 23rd and will be discussing the “Update on the Current and Proposed EU Medical Device Regulatory Initiatives”.

When: June 23rd, 2015

Time: 5:00pm – 7:30 pm

Location: Faegre Baker Daniels LLP

RSVP by June 19th here!

Pearl Employee Publishes Article on RAPS.org

Pearl Pathways is proud of employee Heidi Strunk, as she earned a publication in the RAPS online journal Regulatory Focus.  The article is located on RAPS.org (Login and Password required) and is entitled Types of In Vitro Diagnostics: Clearing Up the Confusion.”

By definition, all in vitro diagnostics (IVDs) for human use are medical devices. This is easily understood – however, with an abundance of acronyms, IVD classification can become complicated. To clear up the confusion, this article considers six types of IVDs:

  • Research Use Only (RUO)
  • Investigational Use Only (IUO)
  • Analyte-Specific Reagents (ASRs)
  • Laboratory-Developed Tests (LDTs)
  • Companion Diagnostic IVDs
  • In Vitro Diagnostic Multivariate Index Assays (IVDMIAs)

There are a number of hurdles to bringing a new medical device to the market, but product classification does not have to be one of them.  This article is a must read for anyone involved in the development of IVDs. Read full article on RAPS.org here.

Join Pearl Pathways at the 5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference

Pearl Pathways is excited to be attending and presenting at the Annual Clinical Affairs & Regulatory Approvals for Diagnostics Conference next week in Alexandria, VA. This conference provides a forum for discussion on the challenges regulators face and strategies used to successfully bring a companion diagnostic to market. This year’s attendees include FDA reviewers, accomplished industry representatives, and numerous regulatory experts.

We encourage you to stop by our booth to meet our talented staff. In addition, we invite you to join us for the Clinical & Regulatory Strategies for Companion Diagnostics Workshop on Wednesday, October 29. Pearl Pathways’ own Gretchen Bowker will be serving as the moderator for the 11:20 discussion on Establishing Realistic Timelines for Companion Diagnostics & Personalized Medicine Development.

Click here to register for the conference. We hope to see you in Alexandria on Monday!

2014 RAPS features Gretchen Bowker as a speaker

Pearl Pathways’ own Gretchen Bowker will be speaking at the 2014 RAPS Preconference Workshop entitled Regulatory Strategy Forum for Biologics. She will be presenting at the 11am session on conducting clinical trials, which will cover the roles and responsibilities of sponsors, investigators, IRBs, and regulatory authorities as they relate to the development of biologic products.

 

What: Regulatory Strategy Forum for Biologics

When: 9 a.m. to 5 p.m. on Saturday, September 27

Where: 2014 RAPS Preconference Workshops (Meeting Room 16A)

Register here!

 

We hope to see you soon at 2014 RAPS: The Regulatory Convergence in Austin!

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.