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Steve Gens is the Founder of Gens & Associates.

Articles

Following a decade of solid groundwork to modernize regulatory information management in life sciences, leading companies have now shifted their focus to how they might exploit this new digital landscape

After a Decade of Regulatory Transformation, What’s Next?

Allows CDMO’s regulatory, consulting services to further expand into the pharma market

Pace Life Sciences Purchases Biopharma Global

Law firm to feature life sciences practice in New Jersey and Philadelphia

Barnes & Thornburg Expands East Coast Presence

Dr. Eduard Cayón is a pharmaceutical industry consultant at bespoke technology and manufacturing supply chain compliance consultancy TDV. He is also the founding partner, VP and a director of pharma auditing organization Asociación Fórum Auditorías (AFA) in Barcelona. The two organizations recently merged with Rephine Ltd, to create the leading global force in GMP audit services. The consolidated organization operates from three primary locations: Stevenage in the UK, Barcelona in Spain, and Shanghai in China.

Dr. Cayón, who holds a PhD in Organic Chemistry, has more than 25 years of professional experience developed in Chemical Research, Pharmaceutical Analytical Development, Pharmaceutical and Food Quality Control, Validation, Auditing and Quality Assurance for the Pharmaceutical industry.

Innovation in pharma manufacturing as paradigms shift and biotech and personalized therapies move through clinical trials at pace

Achieving Efficient, Optimized, and Compliant Production at Scale

Location expands company’s pharmacovigilance, regulatory affairs services

 PharmaLex Opens New Office in Beijing 

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

Legal and Regulatory