ICH Q12 EU Compatibility
The International Council for Harmonization (ICH) works to make global trade in the pharmaceutical industry easier.
Beep…Boop…Bop: Redesigning the Sounds of Medical Devices
Human Factors and Usability professionals have the unique understanding of how healthcare professionals can and do use medical products in a real-world setting. The art and science of developing medical devices that patients can properly interact with and...
Working with Laboratory Benefit Managers: Tips & Best Practices
Working with Laboratory Benefit Managers: Tips & Best Practices Mitchell I. Burken, M.D.Associate Medical DirectorGeneticseviCore Whether you’re in the early stages of working with Laboratory Benefit Managers or are have more experience, understanding how...
FDA Innovative Clinical Trial Designs Launch
The U.S. Food and Drug Administration (FDA) is attempting to modernize the drug development process. A new phase of clinical trial designs was recently announced in an effort to help bring new therapies to patients as quickly as possible. The new pilot...
The Future of Ozone Sterilization
As medical technology continues to evolve, so do medical device sterilization methods. Alternatives to traditional sterilization processes, including ozone sterilization are beginning to change the landscape of the medical device sterilization industry. A recent...
Elizabeth Green – Berklee College of Music
Executive Leadership Support Forum: Boston: Speaker Interview
Kerry Horlbogen – CA Technologies
Executive Leadership Support Forum: Boston: Speaker Interview
Jairus Martin – Bausch Lomb
2nd Annual Pharmaceutical Manufacturing Execution Systems Conference: Speaker Interview
Jennifer Jay – Avedro
Executive Leadership Support Forum: Boston: Speaker Interview
Damy Patel – Varian Medical Systems
6th Semi-Annual Medical Device Supplier Quality Conference: Speaker Interview
FDA opens door to multiarm, multicompany clinical trials
One of the best things that can happen to clinical trials is to make the process smoother. That is exactly what the FDA is trying to do. They have outlined how developers of drugs targeting rare pediatric diseases to streamline their clinical development programs and...
Breakthrough Devices Program: Draft Guidance to Implement 21st Century Cures
On October 25 of this year, the FDA published a draft for guidelines that would help expedite access to medical devices intended for treatment or diagnosis of life-threatening or irreversibly debilitating disease conditions. Industry experts have 60 days to submit...
3D printing could expand medical device regulation: Here’s how
3D printing is changing and saving lives. The FDA is working on creating guidelines to better regulate submissions for 3D-printed medical devices. These guidelines gives the FDA regulators’ thinking on device design, testing of products for function and...
CVS Health to buy Aetna for around $69 billion
CVS Health is set to acquire Aetna for roughly $69 billion in cash and stock. This deal is a first for the industry and is aimed at fending off challenges in retail and health care. This deal will create the first triple threat that includes CVS’s...
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