Services
Research and Clinical Development
Regulatory
Clinical
Biometrics
CMC
Consulting
Management Consulting
Market Access
Patient Engagement
Transaction Advisory
Lifecycle Optimization
Lifecycle Optimization
Real-World Solutions
Real-World Solutions
Technology
Health Storylines
A digital platform that puts patients at the center and intersection of human networks, technology, and science
b.research
A single, unified SaaS solution for all EU Phase 4, Real-World Evidence, and Post-Approval studies
RedCrow
An equity crowdfunding and crowdsourcing platform for healthcare innovation
About
Our team
Our team collaborates to fully understand every aspect of each client’s organization from concept ideation to commercial realization, from innovation to implementation
Community involvement
We work with our local and global communities to create positive change through education, service, and sustainable business practices
800+
employees
90+%
has a PhD and/or Masters
15
languages spoken
30
nationalities
Careers
Job openings
Explore our job openings and find the one that is right for you
Why work at Alira Health?
Alira Health is dedicated to providing market-leading professional development, education, travel, and work-life benefits to all team members
Join our team
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration
Resources
News
Read all the latest from us
Blog
Insights on healthcare innovation and more
Events
Check out our upcoming events
Publications
Discover our latest industry infographics, articles, white papers, and more
Multimedia
Visit our videos, podcasts, webinars, and more.
Latest in the hub
A Tutorial on Modern Bayesian Methods in Clinical Trials
Published: May, 2023
Specific Requirements for Integrated Summaries of Efficacy and Safety in FDA Submissions
Published: May, 2023
Webinar on Advancing Patient Engagement in the Medical Device / MedTech Industry
Published: May, 2023
Services
Overview
Research and Clinical Development
Regulatory Clinical Biometrics CMC
Consulting
Management Consulting Market Access Patient Engagement Transaction Advisory Lifecycle Optimization
Real-World Solutions
Real-World Solutions
Technology
Overview Health Storylines b.research RedCrow
About
Overview Our team Community involvement
Careers
Overview Job openings Why work at Alira Health? Join our team
Resources
Overview News Blog Events Publications Multimedia
Home > Education Hub > Webinar Replay: Trends and Challenges in US and EU Combination Product Landscapes

Webinar Replay: Trends and Challenges in US and EU Combination Product Landscapes

Multimedia
Category:
Regulatory
Published on:
April 29, 2021

The regulatory environment for drug and device combination products is a dynamic one. Guidelines are everchanging and new discoveries are being made daily, sparking an industry evolution.

Rewatch this timely webinar with Alira Health’s Regulatory leadership team featuring key insights and advice for U.S. and EU companies as they map out their own regulatory pathways amid a rapidly evolving landscape.

Featuring cross-border regulatory experts, Mary McNamara-Cullinane, Senior Vice President Regulatory Affairs, Olga Carroll, Ph.D., Vice President Global Regulatory Affairs, Marie-Aude Ohresser, Vice President, Regulatory Affairs, EU, Ainoa Forteza, Manager, and hosted by Aude Ouensanga, Partner.

Watch the session replay below:

Related news

Publications May 25, 2023
The EU Pharmaceutical Package: Introduction to Changes
Alira Health’s Regulatory experts explore how the proposed package will disrupt the European regulatory landscape and what it means for companies.
EU Pharma Regulatory
News February 21, 2023
Access and reimbursement pathways for digital health solutions and IVD devices
Digital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular(...)
Diagnostics Digital Therapeutics Market Access Regulatory Research and Development
Events February 10, 2023
Regulatory Roundup
We are pleased to announce that we are joining Regulatory Roundup as sponsors and speakers. This unique event is hosted by MassMEDIC, the largest regional medtech association in the United States.
Regulatory
Blog January 19, 2023
Medical Device Regulation in 2023: A Window of Opportunity
We spoke with our team of regulatory experts about the recent news regarding the MDR and the opportunity it presents to device manufacturers in 2023.
Medical Devices MedTech Regulatory
Blog January 11, 2023
Regulatory Strategy for Registering Rare Disease Products in the EU: What You Need to Know
Given that the regulation is likely to change considerably, drug developers may need to revisit their development strategy. In the meantime, building a strategy around these evergreen(...)
EU Rare Disease Regulatory
Blog December 21, 2022
2022 Recap: Your Favorite Alira Health Publications
In 2022, the Alira Health team of scientists, strategists, economists, clinicians, and biostatisticians shared actionable insights, industry thought leadership, and leading-edge guidance(...)
Clinical Digital Health Market Access MedTech Pharma Regulatory
Multimedia December 17, 2022
Webinar Replay: Partnering with Patients to Streamline Trial Operations: Protocol to Regulatory Submission in 60 days
Learn how patients and patient advocacy organizations can be directly enabled as powerful partners to facilitate all stages of DCT deployment, from protocol design, recruitment, engagement(...)
Clinical Trials Patient Centricity Regulatory
See all news
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.