Join Women In Bio Capital Region at the University of Maryland School of Pharmacy to discover strategies for risk mitigation, implementation, and evaluation in healthcare products. Our panelists offer invaluable insights for healthcare and life science professionals. Register now!

Program 

9:00 a.m. – 9:30 a.m. Networking and Continental Breakfast
9:30 a.m. – 10:00 a.m. Logistics and Introductions
10:00 a.m. – 10:45 a.m. Panelist Event
10:45 a.m. – 11:00 a.m. Event wrap-up

 

Speaker Bios

Stephanie Brandford, Six Sigma BB, Validation Consultant at Brayearst Validation Consulting

Stephanie is a Carnegie Mellon chemical engineering graduate with a fervor for optimization and compliance. Her journey commenced in the chemical industry, delving into environmental regulations and harnessing her expertise in statistical process control to enhance manufacturing processes, fostering efficiency and sustainability. Venturing into the medical device industry, she carried these principles into the rigorous realm of FDA standards. There, Stephanie dedicated herself to ensuring the safety and reliability of life-saving products. Armed with a Six Sigma Black Belt certification, she assumed a leadership role in validation engineering, guiding teams toward maintaining the utmost quality in manufacturing practices. Brayearst Validation Consulting specializes in applying Six Sigma methodologies to offer a diverse range of validation services. In the Life Sciences industry, adherence to regulations demands evidence of proficient manufacturing processes. Brayearst harnesses our product knowledge and engineering acumen to produce validation documents that withstand rigorous auditor scrutiny.

Julie Doherty, DM, MSN, RN, CIP, CCEP, Assistant Vice President, Research Compliance at the University of Maryland Baltimore

Dr. Julie Doherty is currently the Assistant Vice President, Research Compliance at UMB, providing compliance oversight and strategic program planning for both the human subjects and animal research protections programs. She has been involved in human subjects research since 1997, beginning in vaccine research as a study coordinator, then as the VA Research Compliance Officer, and then onto several positions at UMB, including as Director of Research Compliance, Accreditation, and IRB Operations. In October 2020, she became involved with the UMB animal care and use program. She serves as co-chair of the UMB Research Compliance Coordinating Committee. She has been a site visitor for the Association for the Accreditation of Human Research Protections Program. Dr. Doherty has expertise in conducting both domestic and international site visits. Dr. Doherty has a bachelor’s and master's in nursing and a doctorate in management and holds certifications as both an IRB professional and with the Society of Corporate Compliance and Ethics.

Chitra Edwin, PhD, RAC, Senior Regulatory Affairs Subject Matter Expert/Analyst at Tunnell Government Services, Inc.

Dr. Chitra Edwin is an experienced expert in Regulatory Affairs and Quality Systems in the Life Sciences industry. She is a Senior Regulatory Affairs Subject Matter Expert/ Analyst at Tunnell Government Services, Bethesda, MD. She was a Senior Principal Advisor in Regulatory Affairs and Quality Systems at Covance by LabCorp. Prior to that, she was the Senior Vice President of Regulatory Affairs and Compliance at Spotlight Innovation Inc. She has over two decades of experience in the biotechnology, pharmaceutical, and diagnostics private sector and has been a key member in the development of infectious disease, oncology, and cardiology diagnostic, device, and biologic products that have secured regulatory approval. Her areas of expertise include product development, regulatory affairs, regulatory strategy, regulatory compliance, and quality systems. Dr. Edwin earned a PhD in medical microbiology and Immunology from the University of Minnesota and then trained at the Harvard Medical School as a Research Fellow (Infectious Diseases) at the Brigham and Women’s Hospital, and as an Instructor in Medicine (Infectious Diseases) at the Dana Farber Cancer Institute. She holds Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society in US FDA Regulations and CMC Regulations. She was an Adjunct Professor of Pharmaceutical Sciences at the College of Pharmacy, University of Cincinnati.

Casey Jackson, MS, CCRP, Director, Research Quality Improvement and Compliance at the University of Maryland School of Nursing, Moderator

Casey is a compliance and quality expert with over 20 years of research experience in industry and academic fields spanning pre-clinical bench applications, social-behavioral research, treatment-based clinical research, human research protections, and regulatory science. Varietal experience within these respective fields as a director, research team member, QA manager, educator, and IRB member has given Casey a well-rounded perspective on the complex and nuanced responsibilities inherent in each role. Currently, Casey directs the research quality improvement and compliance program for the University of Maryland School of Nursing, serves as a scientific IRB reviewer for the UMB Institutional Review Board, Director of the Society of Clinical Research Associates National Board, and Chairs the Baltimore chapter of the Society of Clinical Research Associates. She volunteers her time to educate research professionals and laypersons through guest lectures and talks on the topics of regulations, ethics, and good clinical practice. Casey holds a Master of Science in Regulatory Science from the University of Maryland, Baltimore, and a Bachelor of Science in Chemistry and Biology from Towson University. She is motivated by the ethical advancement of technology and healthcare, human research protections, and repair of public opinion on science and research. 

 

Jill Kessler, MS, MSL, CCRP, Sr. Clinical Trial Monitor for the Transplant Oncology Infectious Disease Department at Johns Hopkins University

Jill started her research career in oncology at Johns Hopkins as a research coordinator. After working alongside surgeons, oncologists, and nurses, she found their passion for patient care to be truly admirable and contagious. To strengthen her interests in research and compliance, Jill attended the Maryland Carey School of Law and obtained a Master of Science in Health Law. As she was completing this degree, she gained more knowledge of the intersection of research and the legal system. This additional focus on health law has been instrumental in her career. Jill has worked in quality assurance for the past 10 years. There is always a new safety situation to report, which must be put through rigorous reviews to ensure the data is reflective of this information for future publications. After 12 years in research, she still learns something new daily. Jill is currently a Sr. Clinical Trial Monitor for the Transplant Oncology Infectious Disease Department at Johns Hopkins University. Her focus is monitoring data for several HIV Organ Policy Equity (HOPE) Act studies - which allow for research to transplant organs from HIV-positive donors into HIV-positive recipients. 
 

Pricing Information

• Members: $15
• Students/Post Docs: Free
• Non-members*: $30

*Not a Member? Click here to purchase a WIB membership and gain access to our video library, mentorship opportunities, and more.

Please read WIB's Code of Conduct, In-Person Event Waiver, and Refund Policy.

Note: A confirmation email will be sent after registration has been completed. 

Registration Deadline

April 11, 2024

Walk-Ins Accepted?

No, be sure to register early!

Maximum Capacity

80

Parking Information

Click here for more information on parking. The Pearl Street and Saratoga Garages are closest to the event.

Public Transit Information

Click here for public transit information.

Sponsor