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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: $0.00 Nonmember: $25.00
This webcast will explore the evolving regulations for China NMPA, reviewing regulations related to clinical evaluation, the main changes under Decree #739 in areas of clinical evaluation pathways.

Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.

Member: $365.00 Nonmember: $500.00
This course provides a basic understanding of the legal and regulatory structure of generic drugs in the US.

Member: $0 | NonMember: $25
Introductory webcast for participants to the webcast for participants to the FDA's ASCA, a program in which manufacture.rs may contract with ASCA-accredited test labs to perform testing to certain consensus standards

Member: $0 NonMember: $25
This webinar will provide information on FDA’s Project Optimus and its potential impacts on oncology drug development.

Member: $0.00 Nonmember: $25.00
Learn how a risk-based validation approach can meet compliance requirements and maintain quality while streamlining the validation process.

Member: $2380.00 Nonmember: $2980.00
The Regulatory Affairs Certificate: Pharmaceuticals is achieved by completing four core and five elective courses.

Member: $0 | NonMember: $25
This book aims to document the rules and regulations regarding peri- and post-marketing risk management principles and practices.

Member: $0.00 Nonmember: $25.00
This webcast will review the best methods to evaluate factors that could affect product labeling management.

Member: $0.00 Nonmember: $25.00
Regulatory experts will offer advice pertaining to selecting a target indication, seeking pre-IND advice from FDA, deciding whether to use US or non-US sites for early clinical research, and more.

Member: $0 NonMember: $25
In this webcast, AgencyIQ’s regulatory intelligence team will explore the top regulatory issues and challengers they expect the FDA and life sciences industry to encounter next year.

The 2023 Combination Products Summit is hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by Food and Drug Administration. The Combination Products Summit focuses on solutions for a dynamic industry with evolving regulations

Since 2017, the AI Summit unites AI experts from industry, regulatory agencies & academia to understand challenges and actionable solutions in healthcare & life sciences. AI Summit 2023 is hosted by the AFDO/RAPS Healthcare Products Collaborative.

Member: $1340 | Nonmember: $1570
This hands-on publishing workshop will help you incorporate your working knowledge of the ICH CTD structure into eCTD submission planning, compilation and publishing.

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

Price: $785 Member | $920 Nonmember
This program will focus on regulatory strategies & pitfalls by considering time-to market & risk aspects. By attending, the RA professional will be able to implement the right strategy in his company.

Member $970 | Non-Member $1150
Join us for a review of the current and evolving global regulatory requirements affecting software as a medical device (SaMD).

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.

Price: Member: $1125 NonMember: $1290
This training will give you the skills to ensure all the requirements of the EU MDR are met & provide insight into how clinical evaluation is integrated with risk management and post-market surveillance.

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.

Free
Health situations like the COVID-19 pandemic, are urging us to change in the long research procedures restricted by national regulations as information sharing is the key to rapid innovation in the era of Bi.

Members: $580|Nonmembers: $680
This workshopwill be facilitated by a panel of regulatory professionals who have earned their RAC credential and are subject matter experts in their field.

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.