Preparing your market application and planning the lifecycle management of your development program are critical to moving your product through early-phase trials and achieving commercial success. Approval in the United States and European Union paves the way for a drug’s acceptance in many, but not all, other parts of the world — so which additional countries should you consider incorporating in your trial strategy?
Register for this webinar to explore these and other product development subjects. We’ll also explore case studies from recent product approvals. Topics will include:
- The importance of developing a risk evaluation mitigation strategy, especially if risk factors require limited product distribution
- Making post-approval product changes, such as switching manufacturers
- The expanding role of pharmacovigilance in identifying potential safety issues
Speakers
Kristi Miller, Ph.D., Vice President, Regulatory Affairs, Regulatory Professionals, a division of Premier Research
Kristi Miller leads the team of regulatory professionals in providing strategic and tactical guidance across therapeutic areas and disciplines (CMC, Nonclinical, Clinical, Device and Regulatory Writing). She has over 15 years of experience in the pharmaceutical industry in delivering both regional and international regulatory strategy for pharmaceutical and biotech drug development teams. Her experience encompasses providing regulatory leadership and execution of strategy for products across development (pre-IND through post marketing) in multiple therapeutic areas of immunology/inflammation, ophthalmology, oncology and other rare diseases. Her accomplishments include leading teams to successful global health authority interactions, INDs, orphan drug applications, fast track applications, pediatric strategies and marketing applications.
Kristi received her PhD in tumor cell biology and her previous roles have included positions at Pharmacyclics, and Genentech.
Message Presenter
Christopher Hendry, Senior Director, Technical Services, Regulatory Professionals, a division of Premier Research
Christopher Hendry brings more than 30 years of experience in the development and manufacture of protein biologics with an emphasis on selection and oversight of drug substance and drug product contract manufacturing organizations, development of commercial manufacturing processes, and quality risk management. Utilizing his diverse range of experience at an early stage of the drug development process, Mr. Hendry helps clients expedite and efficiently navigate the development pathway from discovery to market launch. He is also experienced in the transfer and validation of drug substance and drug product manufacturing processes; preparation of CMC sections of INDs, BLAs and CTDs; project management of cross-functional development teams; and GMP facility and equipment design, validation and development master planning. Mr. Hendry has a bachelor’s degree in biochemistry from the University of Maine.
Message Presenter
Lee McGuinness, Executive Director & Global Head, Pharmacovigilance & Medical Device Vigilance, Premier Research
Bio Coming Soon..
Message PresenterWho Should Attend?
- Companies Currently in or Entering Phase 1 or Phase 2
- CEO/COO of Biotechs
- Regulatory Executives
What You Will Learn
In this webinar, participants will learn about:
- The importance of developing a risk evaluation mitigation strategy, especially if risk factors require limited product distribution
- Making post-approval product changes, such as switching manufacturers
- The expanding role of pharmacovigilance in identifying potential safety issues
Xtalks Partner
Premier Research
Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.
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