Blog

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 […]

February 9, 2021

Top tips for a medical writer to prepare a successful NDA

In-Brief: Medical writers must be subject matter experts of the regulatory control inside and out and know the drug under study in clinical research. To prepare a […]

February 11, 2021

Significances and Difficulties of E-labelling in the Medical Device Industries

In-Brief: E-labelling is not new evidence; nor is its use partial to the life sciences business. Creating the latest product data available online adds value across […]

February 17, 2021

How to manage risks in clinical studies? Top 5 tips

In-Brief: Fronting ever-increasing costs of running a clinical trial, sponsors must guarantee they are correctly directing their financial plan and resolving the highest risk areas while […]

February 18, 2021

Challenges faced during FDA Device Approval Process

In-Brief: Effective planning is fundamental to success for any business but an even greater degree in the medical device manufacturing industry. Pepgra covers the top 5 […]

February 23, 2021

Uses and Implementation process of Electronic Data Capture (EDC) in Clinical Trials

In-Brief: Clinical Trial Management Systems (CTMS) are an essential part of every clinical trial. Choosing the right CTMS helps address inadequacies on the operational side of […]

February 26, 2021

Literature Screening and Risk Management for Biosimilars – Challenges and Preventive Measures

In-Brief Biosimilars signify a new class of medical products that will significantly impact the clinical practice of pharmacovigilance literature search. They are the same on an […]

February 28, 2022

Evaluating the results of the literature search and screening

In brief Literature searching is generally accepted as an essential part of the literature review process. It entails a study search in the literature to produce […]

March 1, 2022

What Is the Healthcare Impact of Data Collection?

In brief Regardless of industry, decisions should be founded on facts. The significance of data collecting and analysis based on it The more precise the information […]

March 2, 2022

Guidelines for post-market surveillance of medical devices

In brief Manufacturers perform post-market surveillance to gather and assess experience obtained from medical devices that have been placed on the market and determine the need […]

March 3, 2022

Regulatory Problems about Biomaterials and Medical Devices

In brief All biomaterials and medical devices must comply with various Pharmaceutical Regulatory standards and rules to receive clearance. It covers a range of processes and […]