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FOPE & PharmaState Academy host Session 12 of the PULSE series

Express Pharma

Session highlights: Chief Guest: The event began with a keynote address by Anil Matai, Director General, OPPI India. He further highlighted the importance of thorough documentation, communication with regulators, and the need for a comprehensive understanding of the revised Schedule M guidelines.

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Top 5 takeaways from international hybrid and virtual meeting guidance for pharma

pharmaphorum

When events moved online, societies and associations recognised the wider access afforded by “virtual”, and now, as the world slowly gets back on track, many have opted for a hybrid model that offers the best of both. Here, we take a look at the top five takeaways from the document: 1. The same cannot be said for online events.

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As the Prospect of a Vaccine Approaches, Business and Communications Challenges Are Just Around the Corner

Eye on FDA

Vaccination for COVID-19 not only requires business planning, but communications planning in support of the decisions. Related to both of these first two questions – what sort of documentation will be necessary for an individual – either employee or customer – to present evidence of inoculation?

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog: Biosimilars

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

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How to implement good documentation practice in a GMP regulated plant

GMPSOP

Table of Contents Good documentation practice requires a system for control, implementation, maintenance and archival of GMP related documents and records. To implement good documentation practice and systems the site must assure that GMP documents and records are adequate, approved and in compliance with applicable GMP requirements.

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Chandigarh Calling!

Express Pharma

These events are strategically designed to unlock new opportunities and navigate the intricacies of this evolving landscape. In this article, we delve into the highlights of the Chandigarh Pharma Summit 2023, and showcase the key takeaways and insights from the presentations and discussions at the event.

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Maximizing Revenue for Physicians with Limited Resources: Challenges and Solutions

PharmD Live

Tasks such as billing, coding and documentation consume valuable time and resources, pulling focus away from direct patient care. Medication-related issues, such as adverse drug events (ADEs) and nonadherence, further complicate care delivery. PharmD Live supports retention by: Improving communication to build trust.