regulatory affairs
Digitalization pyramid: How stakeholder interests can lead to a data-driven business
May 14 by Dennis Della CorteAhead of his live Pharma IQ webinar, Dennis Della Corte, Vice-President of Business Development at ZONTAL, shares his thoughts on how life science organizations can achieve digital transformation
Why you need AI to manage increasing global complexity
February 12 by Pharma IQHow AI is enabling pharmaceutical companies to make smarter decisions and stay ahead of the competition
The Future of Pharma: How to manage global complexity
September 10 by Pharma IQThis one day online event will look into the role of AI to reduce workloads and make agile decisions across regulatory and licensing
CMC restructuring: the regulatory implications
September 28 by Pharma IQCritical success factors towards Chemistry, Manufacturing, and Controls (CMC) operational restructuring when faced with regulatory activities.
Emergent regulatory affairs sphere
September 10 by Pharmaceuticals & Biotechnology EditorThe role of regulatory affairs specialists is oft-overlooked, and the industry needs to adapt to stay within regulations.
Early Access Programmes: EU Compliance Handbook
June 28 by Pharmaceuticals & Biotechnology EditorThe increased market awareness for drugs targeting rare and life-threatening diseases has coincided with a rise in the number of patients requesting early access to these medicines.To meet the demand,...
Meeting Regulatory Approval and Improving Distribution Operations across the Middle East
November 21 by Andrea CharlesIn this interview Hassan Bibi, Regional Regulatory Affairs Director NEWAAT - Janssen Pharmaceutical companies of Johnson and Johnson, speaks to Andrea Charles from Pharma IQ, about overcoming the 3...
Early Phase Trials: Reevaluating Asian Markets
February 10 by Pharma IQMuch has been made in recent years of the shift of research and development (R&D) activities, and in particular the movement of clinical trials to Asia and its rapidly expanding emerging markets...
Top 3 Tips for Developing a Globally Applicable Labelling Strategy
January 06 by Andrea CharlesPeter Schroeer, Director Europe, Quality Systems and Regulatory Affairs at Johnson & Johnson, joined Pharma IQ to talk about strategies for overcoming current compliance challenges the medi...
Do Electronic Submissions Save Pharmaceutical Companies Time? 62% says Yes!
August 05 by Pharma IQ NewsWith eCTD submissions taking a firm hold in the US and Japan, they are now making their mark in Europe. Now that eCTD submissions are becoming the preferred format for regulatory submissions in Eu...
How to Build a Strong Strategy for Developing Biosimilars and Approach Bioequivalence Efficiently
July 19 by Pharma IQRichard Peck, Director for Regulatory Affairs at Finox, sums up the main challenges in developing biosimilars, including cost-cutting pressures and the need to take on board regulatory changes and tec...
LEO Pharma & RIM: Successfully Letting Go of Old Habits and Systems
April 25 by Pharma IQNew regulations, new technologies and new internal data management policies necessitate an all-encompassing approach to document management in pharma. In this Pharma IQ interview Susanne Thyssen Ra...