Regulatory Discussion Panel: Understanding Evolving Regulatory Expectations

Thank you, Lundbeck, for hosting this event!

Event Description:

The Pacific Northwest Chapter of PDA is excited to host a panel discussion featuring three dynamic regulatory experts from the drug product and biotechnology manufacturing industry. In a rapidly evolving industry, the insights and experiences of regulatory experts are more crucial than ever to stay ahead of evolving expectations. Our distinguished panelists will share their knowledge and experience, providing valuable perspectives on navigating the complexities of the ever-changing regulatory landscape in the biotechnology and pharmaceuticals industry.

This discussion will include topics related to:

• Demonstrating comparability after process changes
• Contamination Control Strategies for Aseptic Products
• Chemistry, Manufacturing and Control Readiness for Accelerated Programs
• Global Regulatory Convergence for Cell and Gene Therapies / ATPMs

Event Highlights:

• Engaging discussions on current regulatory expectations and trends
• Strategies for success in responding to the current regulatory climate in the biotech and pharmaceutical sectors.
• Opportunities for networking with industry peers and regulatory experts.
• A Q&A session in both panel and small group formats, where attendees can ask questions and gain insights from our esteemed panelists.
• Dinner and drinks included

Who Should Attend:
This event is designed for professionals at all levels within the biotechnology and pharmaceutical industries, specifically those working in late-stage clinical or pivotal-stage drug development, drug product manufacturing, CGT/ATMPs, quality and regulatory sciences. This discussion will provide insights to help you better understand how to set your company up for success now and in the future.

Meet Our Panelists

Erika Pfeiler, PhD

Senior Consultant

ValSource, Inc.

Dr. Erika Pfeiler is a pharmaceutical microbiologist and ex-regulator with 15 years of FDA experience. Dr. Pfeiler currently leverages her technical and regulatory expertise to help clients with a range of issues, including enhancing their contamination control programs in a way to promote patient safety and regulatory compliance. She is passionate about the roles that communication and training play in creating a successful manufacturing environment.

LinkedIn: https://www.linkedin.com/in/erika-pfeiler-ph-d-5ab257265/

Tara Green, M.S.

Owner and Principal Consultant

BioEthica

Tara Greene, M.S., is founder and CEO of BioEthica, LLC and a pharmaceutical quality and regulatory leader with more than 25 years of experience across FDA, industry, and consulting. A former FDA Level III Certified Drug Investigator and Pharmaceutical Inspectorate Drug Specialist, she brings deep expertise in biologics, radiopharmaceuticals, sterile manufacturing, and cell and gene therapies. Tara has led quality organizations such as Inozyme Pharma and Patheon Biologics, and advises companies on inspection readiness, remediation, quality systems, and regulatory strategy from development through commercialization. She holds an M.S. in Biomedical Quality Systems and is an ASQ Certified Quality Auditor.

LinedIn: https://www.linkedin.com/in/tara-l-greene-m-s-19151615/

Meet Our Sponsors

Thank you to our Chapter Sponsors, who make these events possible.

Thank you, Lundbeck, for hosting this Event.

Website: https://www.lundbeck.com/us

LinkedIn: https://www.linkedin.com/company/lundbeck/

ValSource provides a wide range of consulting, commissioning, and validation services that make pharma, biopharma, and medical device organizations even more successful. We are experts in navigating regulated industries and the rigorous requirements that accompany them. Ensure speed-to-market success and eliminate risk with our complete line of services and our experienced staff by your side – from start to finish.

Website: https://valsource.com

LinkedIn: https://www.linkedin.com/company/valsource-inc

Email: bjordan@valsource.com

Almac Clinical Services have been partnering with clients for 30+ years, we set the standard for developing effective supply chain strategies that ensures our sponsors can overcome their unique challenges and deliver supply continuity to patients wherever they are in the world.

We have a range of tools and services to help you achieve this, from forecasting/inventory management, supply chain strategy to global logistics management, end-to-end temperature solutions, IRT set-up and strategy, direct to patient distribution and pharmacy services alongside our clinical packaging and labelling facilities.

When you partner with Almac you are partnering with experts who Supply With Care™.

Website: https://www.almacgroup.com/

LinkedIn: https://www.linkedin.com/company/almac-group/

Email: Michael Hurley - michael.hurley@almacgroup.com

Fisher Scientific, a division of Thermo Fisher Scientific, provides an extensive range of laboratory equipment, life sciences supplies, safety products, and facility management solutions to support research, production, healthcare, and science education sectors. We keep science moving forward by offering over 2.5 million products and extensive support services to the research, production, healthcare, and science education markets around the world.

Website: https://www.fishersci.com/us/en/home.html

LinkedIn: https://www.linkedin.com/company/fisherscientific/

Email: Theresa Hoenes – theresa.hoenes@thermofisher.com