CRS EVENTS

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ROUNDTABLE:
Perspectives on the FDA Guidance for Clinical Decision Software

DATE: November 15, 2022

Clinical decision support (CDS) software is a challenging regulatory space. Should it be regulated as a device? And if it is a device, what does that mean for the software development and testing?

Device regulatory experts Alethea Wieland, President & COO of Clinical Research Strategies and Managing Expert at Advarra Consulting, and Advarra IRB Chairpersons Robert Romanchuk and Erin Odor provided an overview of the final FDA guidance, and conducted a roundtable discussion of case studies to help attendees better understand how the guidance and other device regulations might and might not apply.

PREVIOUS EVENTS

Women in BIO Event
CRS Taam and Dr. Cramer's Presentation

Women in Bio-Pittsburgh: Product Lifecycle in Healthcare – Strategic Steps to Clinical and Regulatory Success

Not all innovators or companies have the same needs. It depends on the product and the stage of development. Do you have a medical device in search of the right regulatory strategy? A drug or biologic that needs regulatory-clinical trial lifecycle management? Maybe you don’t even know the next step to get your product into the hands of those who need it. During this event, Dr. Nisha and Dr. Cramer discussed clinical and regulatory strategies that apply to medical devices and drugs/biologics, with examples of how these strategies were implemented.

Women in BIO Event

Women in Bio-Pittsburgh’s 10th Annual P.O.W.E.R. Event: “Sustainability in an Unstable World.”

It was a packed house for WIB-Pittsburgh’s signature P.O.W.E.R. event. One key takeaway was that sustainability is not just one person’s job in a company. It has to be woven into each role and every decision.

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NOW ONLINE!

Adhering to and Preparing for Changing Clinical Requirements Around the Globe

A talk by Jon Ingi Bergsteinsson M.Sc., Matt Wagener and Alethea Wieland
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NOW ON-DEMAND!

Tips for Accelerating Your Medical Device through the Product Lifecycle

Presented by Advarra Consulting

With Alethea Wieland, President & COO of CRS

Successfully advancing new drugs and life-saving therapies to market for emerging pharma and biotech organizations, involves complex challenges throughout the product development lifecycle. 75% of medical device companies fail and may incur up to $100B in adverse quality costs associated with correcting compliance and regulatory issues.

This webinar discusses key medical device lifecycle product development processes as well as recommends proven strategies for early stage biopharma companies to achieve successful outcomes.

registration required.

VIDEO AVAILABLE!

Regulatory Pathways to Clearance: Transitioning University Discoveries

School of Health and Rehabilitation Sciences Innovation Seminar Series at the University of Pittsburgh

Dr. Julie Cramer, Associate Director of Clinical and Regulatory Affairs of CRS

During this talk, Dr. Cramer provides a regulatory perspective on how to transition your device-based discoveries out of the University. She discusses topics such as how to define your medical device, differences between your device’s intended use and indication, types of device market approval applications/pathways, and Regulatory Pathway Assessments.

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FREE ON-DEMAND WEBINAR!

Tips & Tricks for Customizing a Clinical Trials Program for your Medical Device, IVD, or Digital Therapeutic that Satisfies Regulators, Investors & Patients

with Alethea Wieland, Founder and President of Clinical Research Strategies, and presented by Greenlight Guru

Join clinical trial expert Alethea Wieland as she presents her most valuable tips and tricks to help clinical, regulatory, quality, and marketing teams develop a clinical trial program that fulfills global compliance requirements, meets the needs of patients in various regions around the world, and serves as an ongoing compendium of evidence generation.

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Bridging the Gender Race Divide / Asian American Chamber of Commerce

Clinical Research Strategies’ very own Parul Nisha, PhD, spearheaded Pittsburgh’s Asian American Chamber of Commerce entrepreneurship event at Carnegie Mellon University on May 7, 2022.

May is Asian American Pacific Islander Heritage month. This event celebrated their heritage with a day-long program featuring an Entrepreneurship Keynote and Leadership Round Table with eminent local thought leaders, along with a panel discussion on diverse topics – Biotech, AI/Robotics, Cybersecurity, Finance, Music, Art and Media. The Biotech entrepreneurship panel featured Susan Catalano, PhD, Kanak Iyer, PhD, Hyagriv Simhan MD, MS, and CRS founder, Alethea Wieland.

CMU Panel Discussion

The Biotech entrepreneurship panel featured Susan Catalano, PhD, Kanak Iyer, PhD, Hyagriv Simhan MD, MS, and CRS founder, Alethea Wieland.

Praul Nisha, PhD and Kanak Iyer, PhD organizers of the Pittsburgh inaugural event by the Asian American Chamber of Commerce, held at the Swartz Center for Entrepreneurship at Carnegie Mellon University are featured on KDKA news, May 7, 2022.

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