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Member: $0 | NonMember: $25
This session will cover a comprehensive analysis of the Accelerated Approval program as well as a deep dive into a selection of past examples and precedents.

Member: $545.00 Nonmember: $745.00
This course provides knowledge of fundamental, high-quality auditing practices and skills.

Member: $365 Nonmember: $500
This course provides an overview of the history of risk management, reviews risk management philosophies and examines regulatory requirements and interactions between industry and regulators in the US, EU and Canada

Member: $465.00 Nonmember: $640.00
This introductory course provides an overview of pharmacovigilance across a spectrum of topics, presenting both US and global perspectives.

Member: $570.00 Nonmember: $790.00
This course will introduce you to essential areas of regulatory knowledge for a broad range of pharmaceutical, radiopharmaceutical and biologic products in Canada.

Member: $545.00 Nonmember: $745.00
This course covers the requirements to obtain prescription and over-the-counter drug approvals and other requirements that are in place to ensure compliance with FDA regulations.

Member: $570.00 Nonmember: $790.00
This course provides an overview of the regulations and legislative framework, as well as the EMA entities responsible for medicinal product reviews.

Member: $465 Nonmember: $640
This course provides an overview of the foundation for clinical trials in the US including their historical evolution, ethical conduct and regulations and the responsibilities of parties involved in clinical research

Member: $25.00 Nonmember: $25.00
This course discusses the evolution of the regulatory profession, the professional’s roles and responsibilities and normal roles available within a regulatory organization.

Member: $130.00 Nonmember: $180.00
Orphan Drug Development for Rare Diseases covers every aspect of orphan drug development. Topics include incentives, benefits, patient engagement, designation, marketing authorization, and market access.

Member: $130.00 Nonmember: $180.00
Learn details on labeling for the full lifecycle of human healthcare products, from target labeling through submission and marketing in the US, EU and Canada.

Member: $130.00 Nonmember: $180.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.

Price: Free
This webcast will answer top Regulatory Affairs Certification (RAC) questions. By attending, regulatory professionals will decide if earning a RAC is right for them and how to proceed.

Member: $1340 | Nonmember: $1570
Root Cause Investigation for CAPA is a globally renown methodology for investigating technical performance challenges, particularly in highly regulated industries.

Member: $0 | NonMemeber $25
This webcast will describe the current regulatory framework applicable to mRNA products and explain the regulatory challenges and opportunities that have been enabled with mRNA technology.

Member: $495 | NonMember: $580
Designed specifically for those preparing to take the RAC Drugs exam. This workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.

Member: $175 | NonMember: $200
This workshop will present information on how to register your drug in China and how pricing or market access is determined. What is the best strategy to register and maximize pricing in China.

Member: $335 | NonMember: $395 This workshop provides an understanding for developing an oligonucleotide CMC regulatory strategy. By attending, regulatory & quality professionals will leverage sound CMC submission drafting approaches.

Price: Free
This webcast will answer top Regulatory Affairs Certification (RAC) questions. By attending, regulatory professionals will decide if earning a RAC is right for them and how to proceed.

Member: $175 | NonMember: $200
This webinar will provide practical advice on building or remediating a medical device risk management system that complies with ISO14971:2019, and supports compliance with other medical device regulations

Price: Free
This program is meant to provide attendees a general foundation on the AI topic to help better understand how this may related to their profession now and in the future.

Free
This webcast will provide understanding of common mistakes, errors, and omissions in regulatory submissions with insight to avoid or solve them.

Member: $175 | NonMember: $200
This workshop will provide a thorough understanding of how to prepare for an FDA PAI or BIMO inspection, including Inspection Readiness plans, Gap Analysis and Remediation, and Inspection Logistics.