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ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

The Role of the Local Person Responsible for Pharmacovigilance (LPPV) in the DACHL Region

Ensuring patient safety and compliance with pharmacovigilance (PV) regulations is a critical responsibility for marketing authorization holders (MAHs). For companies planning to market their medicinal products in German-speaking countries—Germany, Austria, Switzerland, and Liechtenstein...

European Union flags outside of EU parliament

Regulatory Sciences

European Pharma Regulations: 2024 Review and 2025 Trends to Watch

Gaining a Competitive Edge: 2024's European Pharma Regulatory Review & Trends to Look for in 2025 and Beyond As the pharmaceutical landscape in Europe evolves rapidly, regulatory frameworks are...

Health care professional meeting virtually with another healthcare professional

Medical Information

A Journey Through ProPharma's REMS Program Support

This fictional story illustrates how ProPharma can seamlessly support a REMS program to ensure patient safety, access to medication, and regulatory compliance. Through scenarios involving healthcare...

Healthcare worker measuring a patient's blood pressure

Medical Information

Patient Support Programs in India: Overcoming Barriers with Healthcare Access

Current Landscape of Medication and Healthcare Access in India India's healthcare system is a complex landscape with significant disparities in access to medical services and medications. Despite...

Medical Information

Optimizing Clinical Trials: Balancing Patient Experience and Commercial Outcomes with Concierge Services

As therapies for rare diseases evolve, clinical trials increasingly require patient -centric care to ensure a smooth and supportive participant experience. This shift is crucial not only for...

Medical Information

Excelling in the JAPAC Medical Information Landscape: Key Considerations and Insights

As a rapidly expanding market, the Japan and Asia-Pacific (JAPAC) region presents a unique and complex landscape for those who are looking to establish a medical information (MI) function. Having a...

Quality & Compliance

WHO Issues Guidance on Antibiotic Pollution Control

On September 3, 2024, the World Health Organization (WHO) released its first guidance to mitigate antibiotic pollution from manufacturing. This directive, which outlines wastewater and solid waste...

FDA Recommendations for Confirming an Ames Positive Finding

Regulatory Sciences

Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding

On November 27,2024, FDA released a draft guidance intended “to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the...

Navigating European Market Access & Reimbursement Strategy for Medical Devices and the Impact of HTAR

Regulatory Sciences

Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe

Background Developing medical devices (MDs), including in vitro diagnostic medical devices (IVDs), requires careful and result-oriented planning throughout the development process. One critical...

final fda guidance ich m13A requirements

Regulatory Sciences

FDA Releases Final ICH M13A Guidance Document

On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”. This guideline provides...

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