ASK THE REGULATOR – Paula Walker from MHRA
A Discussion on Remote Inspections, the Innovative Licensing and Access Pathway, and the Continued Innovation at MHRA

Paula Walker MA BSc, Deputy Group Manager, Inspectorate, Unit Manager, GCP/ GPvP/ GLP, MHRA

  • Share how MHRA adapted to the pandemic through remote inspections
  • Understand the purpose of the recently released Innovative Licensing and Access Pathway
  • Submit your burning questions when you register

The presentation is followed by a panel of industry experts who join Paula to discuss topics presented and questions submitted by the audience.

Expert Panel Includes:
David Fryrear, Senior Vice President, Head of Clinical and Research Quality Assurance, ASTELLAS
Marci Macpherson, Senior Director, Head of Clinical Trial Inspection Management, BRISTOL-MYERS SQUIBB
Michele Weitz, Senior Director, Clinical Operations Standards and Innovation, CLOVIS ONCOLOGY



Registration Cost $199
Registration includes access to the live session on March 25th and the on-demand version for 30 days. Certificate of Attendance available upon request.

For information on government and non-profit discounts as well as group rates, please contact Kristen Hunter at at +1-212-400-6241 or [email protected].


Speakers

Paula Walker MA BSc

Deputy Group Manager, Inspectorate, Unit Manager, GCP/ GPvP/ GLP, MHRA

Paula Walker has been with the MHRA for 12 years, joining in 2009 as a GCP inspector, and subsequently moving to the role of GCP Operations Manager in 2013. Paula is currently the Deputy Inspectorate Group Manager and has been the Inspectorate Unit Manager responsible for the GCP, GPvP, GLP & Laboratories inspection teams since November 2018, as well as a Lead Senior GCP Inspector.

Paula has a BSc in Biomedical Science, MA in Biotechnological Law & Ethics, and a Post-Graduate Diploma in Clinical Trials. Paula has a particular interest in advanced therapy investigational medicinal products and was a member of the EC & EMA working group producing the GCP for ATMPs guidance document.

Paula has worked closely with global Regulators for many years now, developing intelligence sharing and a joined-up global approach to regulation. In Paula’s current role as Deputy Inspectorate Manager she works closely with the Head of Inspectorate in continually ensuring as an Agency the Inspectorate contributes to supporting innovation alongside pragmatic regulation and global collaboration, including working on the Innovative Licensing & Access Pathway (ILAP) Project Board and Steering Group.

David Fryrear

Senior Vice President, Head of Clinical and Research Quality Assurance, ASTELLAS

David Fryrear, M.S., is the Medical and Development organization’s senior vice president and head of the Clinical and Research Quality Assurance (CRQA) organization and has responsibility for providing the global vision, leadership and strategic direction of CRQA at Astellas.

Fryrear is a senior business leader with more than 30 years of experience in the pharmaceutical industry. He has a proven track record in developing and leading global teams to deliver proactive and comprehensive quality strategies to enable excellence and support for pipeline development.

Prior to his current role, David has held a number of senior positions leading quality along the continuum of development. He served as the Senior Director for Research & Development Quality Assurance at Abbvie, where he led a global staff of Clinical, Pharmacovigilance and Quality Knowledge Management QA professionals and was previously the Director of Safety, Efficacy & Customer Information Quality Systems at Eli Lilly and Company.

David earned his M.S. at Butler University College of Pharmacy and Health Sciences, Indianapolis where he Majored in Pharmaceutics and was the recipient of the Eli Lilly and Company Outstanding Graduate Seminar Award.

As a champion of excellence in clinical and research quality assurance activity and risk-based approaches, and an expert in the evolving regulatory and compliance landscape, David has delivered multiple publications and presentations on Clinical and Pharmacovigilance Quality and Quality Risk Management.

Marci Macpherson

Senior Director, Head of Clinical Trial Inspection Management, BRISTOL-MYERS SQUIBB

Marci Macpherson has over 15 years of GCP Quality Assurance experience. At Bristol Myers Squibb (BMS), she established and currently leads a global team dedicated to the management of GCP health authority inspections worldwide. Previously, at Celgene Corporation, she led a global team of Clinical QA auditors responsible for conducting GCP audits, managing health authority inspections, and providing program-level quality oversight to study teams. During her 13-year tenure at Celgene/BMS, Marci has managed inspections in support of the successful regulatory filings of nine new molecular entities and cellular therapies and numerous supplemental indications, as well as managed numerous non-submission related inspections. Marci has a B.A. in Psychology from Northwestern University, an M.S. in Bioscience Regulatory Affairs from the Johns Hopkins University, and holds certifications from the Society of Quality Assurance and the American Society of Quality.

Michele Weitz

Senior Director, Clinical Operations Standards and Innovation, CLOVIS ONCOLOGY

A pragmatist on a mission to make clinical trial regulatory requirements meaningful and accessible to a tough crowd, Michele has worked as both an employee and consultant at pharmaceutical companies of all sizes—from 23 to 111,000 employees, in many therapeutic areas and around the world during her years in clinical development, training, auditing., and operational excellence. She has developed training and presented for Fierce Life Sciences (formerly ExL), SQA, ACRP, Advanstar|CBI, Barnett International, the Multidisciplinary Association of Psychedelic Studies (MAPS), the Institute for International Research, Arena International, and the Global Strategic Management Institute (GSMI).

As Senior Director of Clinical Operations Standards and Innovation (formerly GCP Compliance Operations) at Clovis Oncology, Inc., a company committed to improving the lives of people living with cancer, Michele and her team build ethics and quality into everyday clinical trial operations through developing and executing inspection preparation and participation strategies, advising on GCP compliance issues, responding to audit and inspection findings, developing SOPs and Best Practices, designing and delivering training programs, performing investigations and risk assessments, and managing the TMF system—always with an eye toward how the regulatory requirements came to exist and why they matter to the people who must comply with them.

Date:  Thursday, March 25
Time:  10:00 AM ET – 11:30 AM ET