Discover key differences between FDA and EMA benefit-risk assessment approaches. Expert insights on regulatory requirements, safety reporting, and documentation frameworks. Essential guide for pharmacovigilance professionals navigating both systems. Updated 2024 comparison with real-world examples.

Discover the critical role of Health-Based Exposure Limits (HBELs) in ensuring pharmaceutical safety. This comprehensive guide delves into the science of deriving HBELs, including Permitted Daily Exposure (PDE) values, to manage cross-contamination risks in pharmaceutical manufacturing. Learn about the importance, challenges, and strategic applications of HBELs for industry professionals.

This in-depth guide covers proven approaches for implementing strategic job evaluation and developing aligned grading structures. Learn how to conduct job analysis, choose the right methodologies, create grade levels, manage change, and leverage job evaluation data for compensation planning and talent mobility. Get best practices on point factor evaluation, job ranking, job classification, grading systems, pay equity analysis, and change management. Develop the capabilities to design equitable, transparent job architectures that strengthen workforce management.

The Environmental, Social, and Governance (ESG) landscape is rapidly evolving, with increasing emphasis on sustainability, social responsibility, and ethical practices. Within this dynamic environment, the role of internal auditors is becoming more critical than ever. In this article, we delve into the essential elements of the internal auditor's role in mastering the evolving ESG landscape. Join us as we explore the key responsibilities, skills, and strategies that empower internal auditors to drive organizational success while ensuring ESG compliance.

Process validation is a critical component of ensuring the quality, safety, and efficacy of medical devices. As the medical device industry evolves, it becomes increasingly important to adopt innovative approaches that enhance risk management and change control during the validation process. In this article, we will explore how integrating smart risk and change control management methodologies can optimize process validation for medical devices, leading to improved product quality and regulatory compliance.

Discover the power of Analytical Target Profile (ATP) and Analytical Control Strategy (ACS) in Analytical Method Validation & Lifecycle Management. Learn about key components of ATP and ACS, their significance in maintaining method reliability, and how they ensure quality in pharmaceutical products.

Discover the crucial role of post-market clinical follow-up and post-market surveillance in the medical device industry. Learn about their objectives, challenges, and benefits, as well as best practices for data collection and analysis.

Pharmaceuticals are an essential part of healthcare, and it is crucial to ensure the safety and effectiveness of drugs before they are made available to patients. One of the key ways to do this is through stability testing, which is used to determine how a drug product behaves over time under different storage conditions. However, traditional stability testing methods can be time-consuming and costly, which is why risk-based stability testing has become increasingly popular in recent years.

A modern workplace and business world requires a contemporary approach to managing and rewarding human resources - no second thoughts about that. As organisations deviate from ratings-based annual performance reviews, HR leaders seek unconventional methods to build a structured compensation process and drive positive business outcomes.

We spend about one-third of our lives working and we would not want to spend that time in an unsafe environment that results in dire outcomes such as depression, unhappiness, harassment, health issues and more. We seek safe environments that enable us to thrive. However, fostering a psychologically safe workplace is not one person’s responsibility. It is both for the team and comes from the team.

For an organization on a mission to unlock its productive potential, HR plays the driving force behind its corporate culture. The meaning of HR has molded over the years to go beyond its classic definition and has transformed greatly into something beyond people and administrative tasks. And to solve business issues through the people side of the business, HR business partners step in.

Green hydrogen is gaining a lot of traction in energy and sustainability circles for its unique benefits and innovative applications. In this article, we'll break down everything you need to know to understand green hydrogen, including what it is, how it is produced and transported, its uses, its benefits and how you can learn more.

All over the world, top organizations are looking to build stable yet dynamic organizations that can weather any internal or external challenge. The answer may lie in a management style that is as revolutionary as it is effective - agile performance management. In this article, we will be looking at an introductory overview of this method of management as well as how you can get started and go on to learn more.

The major distinction between pharmacokinetics and pharmacodynamics is that pharmacokinetics (PK) refers to drug movement in the body, whereas pharmacodynamics (PD) refers to the body's biological reaction to medications. In other words, PK refers to a medication's absorption, distribution, metabolism and excretion (often referred to as ADME), whereas PD refers to how biological systems in the body respond to or are influenced by a drug. Simply put, pharmacokinetics is what the body does to the medication and pharmacodynamics is what the drug does to the body.

Competitive and effective sales commission and incentive schemes are essential for keeping top sales personnel. Employees who feel appreciated are further inclined to work more and stay longer, saving your company time and money on turnover. Sales commissions assure your salespeople that they will be paid for their efforts and valued for the time they devote to their jobs.

When it comes to releasing pharmaceutical items to the market, one of the most important tasks is determining the purity of the final product, which necessitates determining its impurity profile. Previously, this primarily applied to contaminants resulting from the manufacturing and degradation of medicinal products. It is now necessary to examine the migration of mobile chemical species from components used in the manufacturing and storage of pharmaceutical goods.

Recent surveys indicate that a substantial number of corporate treasurers fail to manage their company’s FX risk, and that too, is due to a lack of knowledge and understanding. Do you fall into that statistic? Read on for some basics of forex, forex hedging, and how you can learn more.

In simple terms, an organizational design can be defined as a structure that defines how work gets delegated in an organization. It is the administration and execution of a company’s strategic plan. It can also be defined as a step-by-step approach to achieve different yet connected things such as identifying underperforming components of workflow, procedures, structures, and systems, realigning them to match current business realities/goals and finally, developing strategies to implement the new changes.

Every business runs on the ‘Four M's’ — materials, machines, men, and money. The first two, while crucial for business, wouldn't be much use without men. And the time-tested way to get your people to perform is with the last M — money. To combine and unlock the true potential of men and money, every organization needs an effective compensation plan.

HR has demonstrated its ability to quickly and effectively adapt in the face of rapid disruption. During the Covid-19 pandemic, as the need for remote working and digital infrastructure accelerated.

Stability testing is a process utilized for the evaluation and validation of the quality of pharmaceutical ingredients and drugs.

Hybrid workplaces are the future of work. They give employees the freedom to work wherever they choose, while also reducing feelings of isolation and encouraging collaboration.