Legal

Webinar: How to Make Design Part of Your Product Development DNA

October 26, 2020

Many engineers believe they are not creative people. Yet often they are tasked with solving problems, which is a creative activity at its heart. If you need to find ways to be more creative during development projects, we will show you how. Often times members of development teams are isolated to work on their specialty […]

VIDA FDA-Cleared for DL-Based Enhancements to LungPrint

October 1, 2020

  VIDA Diagnostics, Inc. has received 510(k) clearance from the Food and Drug Administration (FDA) for enhancements to its LungPrint solution, including automated deep learning-based lung and lobe segmentation algorithms. This clearance further validates the quality and clinical efficacy of t he company’s artificial intelligence (AI)-powered precision imaging and analytics solutions. The addition of deep […]

Webinar: The Risk-Based Approach to Pharmacovigilance Audits – A Practical Approach to Design and Implementation

September 29, 2020

In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of […]

4th Annual Pharmaceutical Compliance Congress Canada (PCC Canada)

September 14, 2020

Convening top Canadian compliance practitioners and leading experts to exchange ideas and discuss the impact of the latest laws, regulations and best practices for advancing compliance programs

Compounding Pharmacy Compliance

September 14, 2020

The only event of its kind for compounding professionals, providing the necessary information to comply with changing quality standards.

6th Edition Drug Pricing Transparency Congress

September 14, 2020

As the election nears and with the recent flurry of regulatory activity surrounding drug pricing transparency, bio/pharma manufacturers must continuously stay ahead of the ever-evolving changes. Join Informa Connect-CBI’s 6th Edition Drug Pricing Transparency Congress to discuss how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Assess how […]

Webinar: Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing

July 6, 2020

In this two day workshop conference you will learn the different global agencies expectations of equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas […]

Webinar: The Veterinary Drug Approval Process and FDA Regulatory Oversight

June 29, 2020

This two-day interactive seminar will provide attendees with an understanding of FDA’s veterinary drug approval process. The group size is small, generally between 8 and 20 people, with plenty of opportunities to ask questions and discuss issues or challenges that the attendees have experienced.

Free Webinar: Deploying FMV on Any Scale – How to Avoid Common Pitfalls and Friction Points

June 29, 2020

Gain an understanding of the plethora of rate card variations currently deployed in the life science industry during this free, one-hour webinar with Eric Bolesh and Jacob Presson from Cutting Edge Information. Learn about various rate simplification options for consideration when constructing a rate card for your organization. Hear about best practices for deploying on […]

Proteus Digital Health Has Filed for Chapter 11 Bankruptcy Protection

June 18, 2020

The Silicon Valley company develops ingestible sensors that communicate when medicines are taken, plus a wearable patch that monitors the response. At one point, the “smart pill” maker was valued at $1.5 billion according to Forbes. But in recent months, it has struggled to raise additional financing, and furloughed the majority of its employees for […]

Free Webinar: HCP Compensation 101 – FMV Fundamentals

May 26, 2020

Eric Bolesh and Jacob Presson of Cutting Edge Information get back to the basics of HCP compensation in this free, one-hour webinar. Learn about the importance of an FMV process and receive an overview of current FMV approaches in the life science industry. Hear about best practices for determining FMV rates and challenges (and solutions) […]

Clinical Data Management (CDM)

May 25, 2020

This seminar is based on FDA E6 GCP Guidelines which are the basis of effective data quality management. Even if your research is not FDA regulated, the information you learn in this course will help to ensure a robust data collection and management plan.

Webinar: Interdisciplinary Care Rounds: A Key Strategy for Improving Case Management Outcomes

May 25, 2020

During this program, our experts will outline the roles of each team member in the rounding process as well as alternate communication strategies such as care conference, huddles, and internal transfers. Also included will be strategies for planning rounds and how to script team members to optimize time spent discussing each patient.

Webinar: Good Clinical Practice (GCP) – As Applied To The Regulated Bioanalytical Lab

May 25, 2020

This review will cover the development, evolution and application of Good Clinical Practice, (GCP) and will discuss responsibilities of lab personnel in maintaining GCP, observing and enforcing specific blinding protocols, maintaining the integrity and privacy of personal health information under HIPAA and GDPR.

The Veterinary Drug Approval Process and FDA Regulatory Oversight

April 30, 2020

This two-day interactive seminar will provide attendees with an understanding of FDA’s veterinary drug approval process. The group size is small, generally between 8 and 20 people, with plenty of opportunities to ask questions and discuss issues or challenges that the attendees have experienced.

Webinar: FDA Regulations for Commercializing OTC Drug Products

April 29, 2020

The U.S. Food and Drug Administration’s is responsible for regulating the Over-the-Counter Drug market. In this webinar, attendees will learn what is required to market and sell an OTC drug in the U.S. It will provide information on what is an OTC drug, how they are regulated, the different types of products, how to read […]

Webinar: EU’s MDR Effect on U.S. Exports

April 29, 2020

Attend this webinar to learn about the new EU legal requirements for exporting medical devices to the EU. Learn how to prepare for this MDR requirement and include options for selling your device in the EU and the U.S.

Webinar: SMi’s Recombinant Chromogenic Assay as Alternate Methods for the Bacterial Endotoxins Test (BET)

April 13, 2020

Recently, there has been a lot of interest associated with the potential use of synthetic (non-animal based) reagents for bacterial endotoxin testing. This webinar will provide an in-depth overview of the global perspective on the use of such reagents, including their regulatory status. In the hands-on portion of the webinar, we will focus on executing […]

Biostatistics for the Non-Statistician

March 27, 2020

This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

5th China Pharma IP Summit 2020 (CPIPS 2020)

March 27, 2020

Against the backdrop, the 5th China Pharma IP Summit 2020 will once again bring together leading in-house IP counsel, patent prosecutors and litigators, government officials and policy experts from around the world who will share their insights on the latest IP strategies for thriving at a time when regulatory and IP landscape changes are significantly […]

6th Annual Life Sciences Compliance Congress for Specialty Products

March 20, 2020

The life sciences industry’s must-attend conference catered to the unique legal and compliance challenges for specialty pharmaceutical companies focused on rare, ultra-rare and orphan diseases.

4th Annual Pharmaceutical Compliance Congress Canada

March 20, 2020

Convening top Canadian compliance practitioners and leading experts to exchange ideas and discuss the impact of the latest laws, regulations and best practices for advancing compliance programs

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