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The Role of the LPPV in Switzerland and Liechtenstein: Navigating Local PV Responsibilities in DACHL (Part 2)
As we continue exploring pharmacovigilance (PV) requirements in the DACHL region, this second part of the blog series covers the local roles and obligations in Switzerland and Liechtenstein. While part 1 focused on Germany and Austria, this post highlights the unique regulatory landscapes of these...
Job Description Great opportunity for someone looking to launch their career in the sales or administrative fields! Prior experience is not required, but may be helpful. The Weinberg Group, the...
Job Description The Weinberg Group, the leading FDA consultancy, is expanding and seeking an experienced CMC professional to add to our existing capabilities. Qualified candidates must have at least...
Supplier Qualification in the Pharmaceutical Supply Chain
The Food and Drug Administration Safety and Innovation Act (FDASIA), was signed into law on July 9, 2012. This law significantly expanded the FDA’s authority and strengthened its ability to safeguard...
If you’ve spent a reasonable amount of time in an FDA-regulated industry, you’ve most likely been part of an FDA inspection. Should you be more fortunate, you have participated directly with the...
Cybersecurity in Medical Devices: Definitions from FDA's Draft Guidance
Compensating Controls: “A safeguard or countermeasure, external to the device, employed by a user in lieu of, or in the absence of sufficient controls that were designed in by a device manufacturer,...
Quality Agreements and the Pharmaceutical Supply Chain
Over the past several years, outsourcing within the pharmaceutical supply chain has become common. The rise of the “virtual” pharmaceutical company has resulted in a complex supply chain, with the...
On January 4, 2016, the FDA published a draft guidance entitled, “Unique Device Identification: Convenience Kits.” The draft guidance comes after the Agency’s 2013 final rule that established a...
What to do if you experience delays in obtaining IND-related feedback from the FDA: In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations...
Is your project schedule ready to pass the Project Management Institute’s (PMI) "litmus test"? Not sure? Well, the Project Management Team at ProPharma is here to lend a helping hand. Below are some...