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Partnership adds technological offerings to PharmaLex’s repertoire 

PharmaLex Expands Nordic Presence, Merges with DRA Consulting

is Chicago office chair of the Health Law Practice Group at the law firm, Quarles & Brady LLP. She advises a range of health care clients on regulatory and transactional matters, including assisting pharmacy and wholesale distributors in developing regulatory compliance strategies.

 is a partner at Quarles & Brady. He uses his extensive experience as an attorney representing pharmacies, pharmacists and other health care providers – along with his background as a pharmacist – to advise on regulatory compliance and defend clients in litigation matters.

is an associate at Quarles & Brady. He has extensive experience with the 340B Drug Pricing Program and also regularly assists pharmacy benefit managers (PBMs), utilization review agents (URAs) and third-party administrators (TPAs) in navigating the complex and evolving regulatory landscape facing these entities.

As a result of the United States Supreme Court’s overturning of Roe v. Wade and Planned Parenthood v. Casey, pharmacy providers are looking to state laws and other recently issued federal guidance in determining how they can compliantly meet patient needs and deliver medications.

Navigating Abortion Restrictions Post Dobbs: Considerations for Pharmacy Providers

Pharmaceutical distribution today is anything but monolithic. While companies in this space are grappling with issues ranging from inflation and supply chain disruption to workforce scarcity and DSCSA implementation, there’s still plenty of room for smaller players to stake out part of the terrain to call their own

Pharma Distribution: Carving New Ground

Frits Stulp is Managing Director of Iperion, a Deloitte company, where he leads a team of regulatory/IDMP experts active in various projects to deliver value to both pharmaceutical companies as well as regulators. Frits  is also involved with CTADHL ( www. CTADHL.org), a not-for-profit organization Call To Action Delivering Health Literacy, as part of his efforts to support transatlantic data harmonization based on IDMP.

Aida Demneri is a Partner in Deloitte’s Risk Advisory practice based in the Netherlands. She leads the European and the Netherlands’ Life Sciences and Health (including MedTech) Risk Advisory and Regulatory practice. She has over 20 years of experience in Risk Management, Regulatory and Compliance. With her team Aida works to help clients overcome challenges in their journey towards a responsible Future of Health. Specific topics include Regulatory Excellence & Transformation, Extended Enterprise Risk Management, Cyber/Security/ Data, and IT Quality.

Faster approvals, more accurate and timely medicines monitoring—all enabled by harmonized, consistent and reliable data—will drive improved patient outcomes.

Harnessing the Potential of Data to Deliver the Future of Healthcare

The EPCIS communications standard is “recommended,” and trading partners are identified

FDA Issues Two Draft Guidances for DSCSA Compliance 

The Health System Owned Specialty Pharmacy (HOSP) Alliance‘s Melissa Goff responds to the news of the FTC investigation into PBM practices news and outlines the alliance‘s vision for the integrated specialty pharmacy industry

PBM Inquiry: Fresh Hope for HOSP

Features an ATP solution to allow for efficiency

Systech Partners with Spherity on Facilitating DSCSA Compliance

IQVIA’s Jens-Olaf Vanggaard discusses the challenges of managing regulatory intelligence on a global scale.

The Future of Managing Regulatory Intelligence

The clock is ticking on a massive effort to bring interoperable, electronic tracking of pharma shipments in the US

Countdown to 2023 DSCSA Compliance

A recommended checklist for manufacturers as they enlist distributor and 3PL support—and the important questions they should be asking themselves  

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