Blogs

16/01/2024

Blogs

Navigating Quality Excellence: An Insight with Dr. Upendra

The role of quality management in pharma has evolved into a crucial component, ensuring the highest standards of patient safety and efficacy. Dr. Upendra Quenim, a luminary in the field, leads the way in navigating this ever-changing terrain. In a recent interaction, we explored the role of Quality in Pharmacovigilance through the lens of Dr.…

04/01/2024

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by Dr. Esraa A. Zoubi

Ensuring Pharmaceutical Safety in Jordan

An Insightful Conversation with Dr. Esraa A. Zoubi, General Manager Advisor for Regulatory and Pricing Affairs at the Jordan Food and Drug AdministrationJordan FDA is the first Arabic regulatory authority, that has well-established regulations that govern drug efficacy and safety. In an exclusive interview with Dr. Esraa A. Zoubi, General Manager Advisor for Regulatory and…

22/12/2023

Blogs

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by Vrushali Negandhi

The Evolving Role of Quality Assurance in Pharmacovigilance: Leading proactive risk-based approach in Patient Safety

In the wake of the MHRA's safety data review leading to the recall of pholcodine-containing medicines in the UK*, a burning question came to my mind: Could proactive Quality Assurance (QA) practices, including early signal detection and collaboration with healthcare providers for patient insights, have prevented the need for such widespread recalls and averted widespread…

19/12/2023

Blogs

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by John Robert

Parables of a Project Manager

PARABLES OF A PROJECT MANAGERIn one sense, ‘everyone is a project manager’ in an organization. The one who has planned for a vacation has already been in the role of a project manager. When you are planning a vacation, what do we start with? We begin with the destination. Beginning with the end in mind…

11/12/2023

Blogs

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by Mike Teiler

Do You Manage Projects Like a Bungee Jump?

The Rubber Band and the Bungee Cord Why is it that most projects are more like bungee cords than like rubber bands? No, no….I don’t mean because they always seem to snap back in the face of the project managers! If you think about it, a rubber band and a bungee cord are exactly the same…

10/12/2023

Blogs

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by Sachin Bhandari

Qualifying SaaS, IaaS: Creating Quality Agreements

As we move to Industry 4.0, it is imperative that along with processes, technology will also go through transformation. Once such transformation is using cloud services for Software and Hardware. The following article talks broadly about considerations to ensure GXP compliance, the attached presentation gives a spectrum to be covered during creating such agreements. In…

09/12/2023

Blogs

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by Rajaram Iyer

LIFE or LIMB?- A question that changed my perspective on Medical Treatment.

In 2011, a physician from USC wrote a piece on a rather unusual topic: How Doctors Die? His article presented a novel perspective on an ethical question surrounding end of life care, i.e. how much should clinicians do to save life for terminally ill patients? And his view was inclined towards ‘less is more’. And…