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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
What will the FDA do in 2023? In this timely, lively and informative event, regulatory analysts from POLITICO's AgencyIQ will explain what regulatory professionals should anticipate in the year ahead.

Member: $0 | Nonmember: $25
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.

Member: $147.50 Nonmember: $197.50
This 11th edition presents information covering all lifecycle stages of regulated healthcare products in the US.

Member: $130.00 Nonmember: $180.00
This book takes a comprehensive look at global regulations, guidance, and incentives for the development of products for the pediatric population.

Member: $0.00 Nonmember: $25.00
Learn about the contributing factors to building change control system that can help manage risk as well as metrics to consider to drive success.

Member: $0 | NonMember: $25
Join a dynamic discussion with regulatory affairs leaders from pharma and biotech on leveraging technology to drive strategic impact. Hear first-hand how these leaders are making a difference.

Member: $145.00 Nonmember: $200.00
Regulation of Regenerative Medicines: A Global Perspective takes a look inside the rapidly evolving cell therapy, gene therapy, and tissue engineering landscape in the US and other key world markets.

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

Member: $37.50 Nonmember: $62.50
A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.

Member: $3,625.00 Nonmember: $4,535.00
The Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals is achieved by completing six core and eight elective courses.

Member : $10.00 Nonmember: $15.00
An EU reference guide with entries in biologics, medicinal products, and medical devices.

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: $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.

Member: $0 | Nonmember: $25
This presentation will provide a practical approach to aid regulatory professionals drafting a biocompatibility risk assessment to use in preparing various regulatory submissions.

Member: $1340 | NonMember: $1570
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.

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.

Member: $0 | NonMember: $25
Join a dynamic discussion with regulatory affairs leaders from pharma and biotech on leveraging technology to drive strategic impact. Hear first-hand how these leaders are making a difference.