Pre-IND Meeting Requests and Avoiding CMC Related Clinical Hold

Join us for a presentation as we share real-world experiences as a Pharmaceutical CDMO with a well-established history of formulation development and commercial manufacturing.

Register Free: https://www.pharmtech.com/pt_w/avoiding-clinical-hold

Event Overview:

This webinar highlights the advantages associated with a pre-IND meeting request and briefing document submission for a drug development program. Learn more about what topics should be addressed and learn how to successfully prepare CMC and eCTD activities in accordance with regulatory requirements to increase the chance of a successful IND submission and avoid clinical hold.

Key Learning Objectives:

• Significance of pre-IND meeting requests, briefing packages, and ongoing FDA correspondence
• Successful preparation of CMC and eCTD activities in accordance with regulatory requirements
• Understanding regulatory expectations and avoiding issues

Who Should Attend:

• Heads of Pharmaceutical Development, Analytical and Clinical Activities
• Pharmaceutical Business Development Professionals
• Regulatory Affairs Professionals
• Quality Professionals
• Company Founders, CEO, CSO

Speakers:

Wayne Wiley, RPh
Vice President, Regulatory Affairs and Pharmacovigilance
Societal™ CDMO

Wayne Wiley, RPh brings over 35 years of experience in pharmaceutical regulatory affairs to Societal™ CDMO, serving as the site’s vice president of regulatory affairs and pharmacovigilance. Wayne is an experienced manager with broad experience and success, supporting regulatory agency meetings in addition to IND, NDA, ANDA, DMF, and ROW filings and approvals. Wayne has a strong understanding of regulatory, clinical, development, and life cycle management filing requirements, including post-approval support for phase IV, pharmacovigilance, and supplemental approvals. Prior to joining Societal™ CDMO, Wayne held various positions of increasing responsibility at Alkermes, Elan Drug Technologies, and Solvay Pharmaceuticals.

Wayne is a registered pharmacist graduating from the Mercer University School of Pharmacy. He has delivered lectures in regulatory affairs and pharmacovigilance for the University of Georgia School of Pharmacy: Master of Science in Regulatory Affairs program and serves as an adjunct professor. He has also supported the Mercer School of Pharmacy: Doctor of Pharmacy Preceptor training program. He is a member of RAPS, DIA, and AAPS.

Speaker’s Email: wayne.wiley@societalcdmo.com
Speaker’s LinkedIn: R. Wayne Wiley, RPh

Karen Jozefiak
Director of Regulatory Affairs
Societal™ CDMO

Karen Jozefiak brings 20 years of experience in pharmaceutical regulatory affairs and quality to Societal™ CDMO. She is currently the director of regulatory affairs. Karen’s experience includes CMC, electronic submissions (eCTD), drug safety reporting, and labeling in NDA and ANDA filings. Prior to joining Societal, Karen held various positions of increasing responsibility at Par Pharmaceuticals (formerly Qualitest). Karen holds a BS in Chemistry from San Diego State University. She is a member of RAPS.

Speaker’s Email: karen.jozefiak@societalcdmo.com
Speaker’s LinkedIn: Karen Jozefiak

Sharon McDowell
Associate Director of Regulatory Affairs
Societal™ CDMO

Sharon McDowell has more than 30 years of experience in the pharmaceutical contract manufacturing industry, specializing in the areas of regulatory compliance and new drug applications. Sharon currently works for Societal™ CDMO, serving as the associate director of regulatory affairs. Prior to joining Societal™ CDMO, Sharon held various positions of increasing responsibility at Mikart, LLC.

Sharon’s career experience includes eCTD drafting and submissions for various IND, NDA, ANDA, DMF, and ROW filings. Sharon has a strong background in the overall drug development process and in providing teams with regulatory support throughout the entire product lifecycle.

Sharon received her BS from the University of Georgia. She also holds a Regulatory Affairs Certification and is a current member of RAPS.

Speaker’s Email: sharon.mcdowell@societalcdmo.com
Speaker’s LinkedIn: Sharon (Warbington) McDowell

Register Free: https://www.pharmtech.com/pt_w/avoiding-clinical-hold