12 September 2018
12:00 – 1:30 pm EDT
Getting a product approved by the European Medicines Agency (EMA) can be daunting, especially for companies that have little experience with this unique and complex process. Within the EMA, the Committee for Medicinal Products for Human Use (CHMP) conducts a scientific data review and recommends whether or not the drug or biologic should receive marketing authorization.
This webcast will walk you through how to prepare for and manage CHMP meetings, as well as how to identify and address issues prior to submission.
Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Learning Objectives
Upon the webcast's conclusion, you will be able to:
- Define the EMA review timeline
- Evaluate how to prepare for the four different types of CHMP meetings you may face
- Expert Group meeting
- Scientific Advisory Group (SAG) meeting
- Oral Explanation
- Pharmacovigilance Risk Assessment Committee (PRAC) meeting
- Discuss pre-submission activities that will help identify and avoid issues
Who should attend?
- Companies seeking to get products approved by European Medicines Agency (EMA)
Speakers
Kell Cannon, principal, 3D Communications
Kell Cannon brings more than 20 years of U.S. and global lifecycle and pharmaceutical marketing expertise to 3D's clients. Cannon uses his analytical and organizational skills to help clients identify the strengths and weaknesses in their data and define their competitive differentiation. He has developed rigorous processes to help clients analyze and prepare their regulatory submissions and FDA advisory committee presentations. This assistance enables companies to win approval, expedite product access and achieve competitive reimbursement. Cannon has held leadership positions at Roche, Novartis, Ciba and Merck in clinical trial strategy, label negotiations, brand positioning and advocacy development.
Pete Embley, senior director, regulatory science, Voisin Consulting Life Sciences (VCLS)
Pete Embley has over 20 years applied industrial and commercial biopharmaceutical experience, including seventeen years in regulatory science; working within the generic, R&D and Contact Research Organization (CRO) industries. He has a strong grounding in EU legislation and filing strategies. Embley has developed both regional and global strategic perspectives coupled with commercial acumen and experience working within multicultural project teams. His collective experience reflects a balance of regulatory experience in drug development and lifecycle management. Embley has managed several Abbreviated New Drug Application (ANDA) during his time at Ranbaxy (circa 2007) and trained/mentored regulatory inductees in the US/EU generic submission process at Chugai, Ranbaxy and PPD.