Countdown to Crunch Time: How Early and Continual Regulatory Engagement Leads to Regulatory and Commercial Success

Life Sciences, Clinical Trials, Pharmaceutical Regulation,
  • Monday, April 22, 2024 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

In the webinar “Countdown to Crunch Time: How Early and Continual Regulatory Engagement Leads to Regulatory and Commercial Success,” industry-leading regulators with extensive experience in both the biopharma and the CRO space engage in a not-to-be-missed, dynamic conversation. Participants will uncover vital strategies for navigating regulatory pathways seamlessly. By avoiding common pitfalls that could jeopardize submission deadlines, attendees will gain invaluable insights into safeguarding project timelines.

Additionally, this webinar will shed light on the often-overlooked advantages of early and continual engagement with regulatory agencies and how proactive collaborative efforts in the early stages can significantly enhance efficiency and mitigate risks. By sharing lessons learned and expert strategies, participants will be well-equipped to streamline their regulatory journey, ensuring overall success.

Register for this webinar today to gain insights into the advantages of early and continual regulatory engagement.

Speakers

Linda Bowen, Pfizer

Linda Bowen, MS, RAC (US, EU, CAN), FRAPS, Business Operations and Integration Lead, Oncology Global Regulatory Strategy, Pfizer

Linda Bowen, MS, RAC (US, EU, CAN), FRAPS has 40 years of experience in the biopharma industry, of which 30 years were spent in regulatory strategy, intelligence and policy roles. She is the Business Operations and Integration Lead for the newly formed Pfizer Oncology Global Regulatory Strategy group. She was previously Executive Director, Chief of Staff and Head of the Regulatory Centers of Excellence at Seagen, Inc; Head of US Regulatory Policy & Intelligence at Sanofi and has held senior regulatory positions at Bayer and GSK.

She is a past two-term member of the RAPS Board of Directors, current Chair of the Industry Board and immediate past Chair of the NJ/NY RAPS Chapter. She attained regulatory affairs certification (RAC) for the US, Canada and Europe, and was an inductee to the 2011 Class of RAPS Fellows and honored with the RAPS 2020 Founder’s Award. Linda was also honored for her volunteer efforts with the Drug Information Association’s 2012 Excellence in Volunteer Leadership, the 2019 Americas Inspire Awards and the 2022 Global Inspire Award – Community Engagement. Linda is the past Chair of the DIA Regulatory Affairs Community and founder of the DIA Regulatory Intelligence Working Group.

Message Presenter

Aman Khera, MBA, FRAPS, FTOPRA, Vice President, Regulatory Science, Strategy and Innovation, Worldwide Clinical Trials

Aman Khera, MBA, FRAPS, FTOPRA, Vice President, Regulatory Science, Strategy and Innovation at Worldwide Clinical Trials has been providing global strategic direction in regulatory affairs for nearly three decades. She has built her career on maintaining fastidious patient care with the pragmatism needed to help clients achieve effective regulatory and development strategies. With a deep foundation in global regulatory affairs and the life sciences industry, Aman looks at how regulatory, strategy and innovation intersect within healthcare. She is a 2021 PharmaVOICE 100 honoree and is recognized as one of the most influential and inspiring people in the life sciences industry. An advisor, board member and mentor in the industry — and most importantly as a family member of the care circle for a pediatric rare disease patient — her passion extends beyond just work. Aman is available to consult with companies of all sizes, as well as their funding entities, to support their goals — with the primary aim of serving humanity as a whole.

Message Presenter

Who Should Attend?

This webinar will benefit Vice Presidents, Directors, Managers, Department Heads, Scientists and Researchers working at pharmaceutical and biotechnology companies:

  • Clinical affairs
  • Clinical R&D
  • Clinical research
  • Clinical operations
  • Medical affairs
  • Project management
  • Regulatory affairs
  • Strategic planning

What You Will Learn

Attendees will gain insights into:

  • The pitfalls to avoid that could derail the deadlines
  • The hidden benefits of early and continual engagement
  • The lessons and master strategies to streamline and drive regulatory success

Xtalks Partner

Worldwide Clinical Trials

Worldwide Clinical Trials (Worldwide) is a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications, from discovery to reality. Our full-service clinical development capabilities include bioanalytical laboratory services and Phase I-IV clinical trials, as well as post-approval and real-world evidence studies – all powered by our talented and accessible team of clinicians, scientists, and researchers who bring their first-hand expertise to each clinical program.

At Worldwide, we understand that each customer and project are unique, so we take a collaborative and personalized approach to identify and meet specific needs and goals. Anchored in our company’s scientific heritage, we are therapeutically focused on cardiovascular, metabolic, neuroscience, oncology, and rare diseases. We apply this deep therapeutic knowledge to develop flexible plans and quickly solve problems in the rapidly evolving clinical development landscape.

Our team of 3,000+ professionals spans 60+ countries, and believes that through collaboration, and a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays an important role in making a world of difference for patients and their caregivers. We are united in cause with our customers to improve the lives of patients through new, innovative therapies.

For more information, please visit www.worldwide.com or connect with us on LinkedIn.

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