Regulatory NewsRegulatory News
FDA, EMA tout benefits of parallel scientific advice program
Posted 17 March 2022 By Joanne S. Eglovitch
Regulators described how the parallel scientific advice (PSA) program offered by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) saves sponsors time and resources by bringing both health authorities to t...
Regulatory NewsRegulatory News
PFDD: FDA finalizes guidance on identifying what’s important to patients
Posted 28 February 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) on Friday finalized guidance to assist sponsors collect and submit “important” information from patients and caregivers used for medical product development under the agency’s patient-focused dru...
Regulatory NewsRegulatory News
ICH guide provides clarity on estimands, sensitivity analyses
Posted 31 January 2022 By Joanne S. Eglovitch
The International Council for Harmonization (ICH) has issued ICH E9 (R1) training materials meant to improve the planning, design, analysis and interpretation of clinical trials by defining suitable estimands.  
Regulatory NewsRegulatory News
Strategic hiring and retention needs dominate PDUFA VII subgroup discussions
Posted 23 April 2021 By Joanne S. Eglovitch
Finance subgroup summaries from January and February show the need to attract and retain talent as a priority; the topic was discussed in at least four of the six meetings. The PDUFA finance committee met six times since January.
On-demand On-demand
Best Practices for Building An Efficient Literature Review Process
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review simple, pragmatic approaches and tools to focus on the high value work of CER preparation by reducing the time to complete low value administrative tasks.
Books Books
Introduction to the Due Diligence Process, Second Edition
Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
On-demand On-demand
A Roadmap for Driving Messages through Development, Submission and Beyond
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Participants will learn to build persuasive arguments that help smooth project management and regulatory strategy during development, submission and beyond.
On-demand On-demand
How Huvepharma Maintains Quality and Innovation in a High Growth Environment
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand
Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand
Efficiency and Technology Pave the Way for the New Age of Narrative Writing
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
You will also learn how to add efficiency in your narrative process through the use of streamlined safety data reporting and implementation of technology.
On-demand On-demand
Navigating Today’s Regulatory Trends to Successfully Manage eCTD Submissions
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will feature an overview of best practices to create successful eCTD submissions in a rapidly changing environment.
On-demand On-demand
Stay on Track and Get Some Sleep: Marketing Application Best Practices
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory experts will offer tips and guidance for acceleration, submission leadership, and regulatory strategy from that you can apply to your marketing application to help ensure a successful submission.
     
  •  
  • 1
  •  
  • 2
  •  
  • 3
  •  
  • 4
  •  
  • 5
  •  
  •  

All Results

On-demand On-demand

Best Practices for Building An Efficient Literature Review Process

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review simple, pragmatic approaches and tools to focus on the high value work of CER preparation by reducing the time to complete low value administrative tasks.
Books Books

Introduction to the Due Diligence Process, Second Edition

Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
On-demand On-demand

A Roadmap for Driving Messages through Development, Submission and Beyond

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Participants will learn to build persuasive arguments that help smooth project management and regulatory strategy during development, submission and beyond.
On-demand On-demand

How Huvepharma Maintains Quality and Innovation in a High Growth Environment

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand

Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand

Efficiency and Technology Pave the Way for the New Age of Narrative Writing

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
You will also learn how to add efficiency in your narrative process through the use of streamlined safety data reporting and implementation of technology.