pepgra

April 19, 2020

Periodic safety update reports (PSURs)

Introduction PSURs are pharmacovigilance documents that provide risk-benefit balance assessment. The notion of PSUR is to offer a wide and complex evaluation of risk-benefit balance of […]

March 27, 2020

Medical Literature Monitoring and Entering Negative Reaction Reports

March 3, 2020

Output Of The Post Market Surveillance (PMS) Plan

In Brief The new European Union (EU) post-market surveillance (PMS) plan would act as a detailed tool for benefit-risk evaluation for medical devices. If the […]

March 2, 2020

Medical Device Classification In The European Union

In Brief Different medical devices have different parameters through which it can be classified. With that reasoning, it does not make sense to subject all medical […]

February 18, 2020

Preparing For The Future: The New European Union Medical Devices Regulation

In Brief For long, medical device regulations continued to remain stagnant till such time that the world was struck with the hip replacement and breast implant […]

February 11, 2020

Overview Of The Main Differences During New Product Development Between Medical Devices And Medicines

In Brief Medicines and devices that are supposed to be launched are based on industry composition where above 80% small and medium-sized companies require medical devices […]

February 4, 2020

E-Dossier Submission: Regulatory And Procedural Guidance

In Brief This particular write-up presents a background about e-dossiers that are submitted to regional authorities by pharmaceutical companies for drug registrations. The write-up highlights the […]

January 10, 2020

Challenges And Solutions To Pharmacovigilance Literature Screening

1.0 Background Adverse drug reactions assume much significance in terms of risk associated with safety of patients and could make a major impact on costs related […]

December 17, 2019

New Medical Device Regulation: Implications for Medical Device Manufacturers

1.0 Background The implementation of the new medical device regulations (MDR) on 25th May, 2017 has presented medical device manufacturers with several drastic changes in the […]

November 28, 2019

Relevant Medical Databases And Search Engines For Periodic Literature Screening

Are you looking to collect evidence for your medical writing projects? If the answer is YES, then you should always bank upon the most recent and […]