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.

Experienced project manager joins Pearl Pathways

shawn-knoppPearl Pathways is pleased to announce the hiring of Shawn Knopp, PhD as an Advisor serving medical device and biopharmaceutical life science companies.

Knopp brings to Pearl Pathways over 15 years of experience in multi-disciplinary life science roles including project management, product development, regulatory, engineering, and manufacturing.

Diana Caldwell, President and CEO shares, “Our clients will benefit from Shawn’s extensive leadership experience navigating a variety of regulatory compliance challenges in large multi-nationals and small startups… His past experience working as in independent consultant in the industry allows him to adapt to the dynamic needs of the biopharmaceutical and medical device companies we serve. We are so pleased to welcome Shawn to the team.”

To view the full press release, please click 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.

Gretchen Bowker to lecture at Tools & Techniques in Translational Research course

new-ctsi-logoOn November 22nd, Pearl Pathways COO, Gretchen Bowker, MS, RAC, FRAPS will lecture on the topic “Drug Development:  Goin’ to the FDA” for the Indiana Clinical and Translational Sciences Institute (CTSI) Fall 2016 course – Tools and Techniques in Translational Research.  The course is designed to provide an understanding of the basic technologies and techniques used in translational research today.  Translational Research is the application of basic discovery to human health and disease. Bowker is one of the faculty lecturers helping Purdue, Notre Dame, and IU Bloomington advanced graduate students, clinical and research based postdoctoral fellows gain the skills needed to succeed in translational research.  Check out Indiana Clinical and Translational Sciences Institute (CTSI) to learn more about their role in accelerating clinical and translational research.