Medical Device Market Access in the ever-changing healthcare sector.

The Essential Guide to Safety, Quality, and Trust Across Regulated Industries

Yes, as you heard it. You can use the risks to your advantage....

Achieving Quality and Conformity

Key Skills for Professional Success

Understanding the Impact of Limited L&D Resources

The laws that govern the field of cybersecurity are always changing along with the industry.

Using data analytics in audit to your advantage is possible

The significance of Environmental, Social, and Governance (ESG) issues in company operations has gained momentum in recent times.

The term "immunogenicity" describes a substance's capacity to trigger an immune response in humans;

The effective management of interest rate risk holds significant importance for European banks within the ever-evolving banking industry.

Medical device efficacy and safety have always been of utmost significance in Europe.

Pediatric toxicology focuses on the adverse effects, remedies, and prevention of hazardous chemicals in kids.

Effective procurement procedures are essential for any business to succeed in the constantly evolving global marketplace of today. Over 30% of contracts perform poorly due to inadequate contract management, and at least 10% of corporate value is lost as a result of ineffective or inefficient procurement processes, according to the World Commerce and Contracting Association (WCC). 

As stated by the World Economic Forum, over half of the global economy output, resulting in USD44 Trillion, is "moderately" or "highly" impacted by nature. As a result, the notion of nature-related risks has received a lot of attention recently as organizations all over the world continue to be negatively impacted by environmental degradation.

Uncovering the Hidden Truth

How to use Psychometric Tools to Match Your Organization's Objectives?

Exploring into the herbal industry of Europe.

Our previous blog we spoke of Advanced E-Pil. So, let’s explore on something that many of us didn’t know, the science behind cannabis in the pharma industry.

In our previous blog we spoke on what is PK/PD? In this blog, we will be looking into something related with technology.

On our previous blog we spoke on impurities. So, let’s explore something new. Do you know what’s the connection between a drug and human body? Well on todays blog will find out some of the common doubts on PK & PD.

In this blog, impurities are explained in depth on the pharmaceutical approach.

In our previous blog, we gave you a clear idea of what is a cell, how it functions, and the purpose behind it. In this blog we are will be sharing something that is interesting about cell banking and testing. 

With the gradual increase of these Systems, many manufacturing companies took this as an advantage to dwell into the field of pharma manufacturing. As a result, a need raised to come up with a foolproof and risk-free system.

When ICH initiated the guidelines on Clinical studies and Clinical Trials, a set of principles and practices were laid out to ensure that the design and structure of conducting clinical trials.

Sponsors are under additional pressure to increase efficiency while preserving quality as a result of clinical studies becoming more complex as more data is collected.

Characterization and analysis of advanced therapy medical products (ATMPs) are crucial for delivering the crucial chemistry, manufacturing, and control (CMC) data required for submission in investigational new drug applications.

For products made from cells, cell bank characterization is a crucial quality-control procedure. A well-established cell bank is essential to guarantee there is an appropriate supply of similar cells for use for the course of the product's complete life span once a cell line is selected as its biological source. 

Children should receive medications that are customized for them. Over the past few decades, there has been a growing awareness of the necessity of involving children in the drug development process.

Key Account Management (KAM) in the Medical Sector, Prescription authority has recently been divided across organizations, committees, or networks of medical, social, administrative, payer, and patient representatives.

The evaluation of spontaneous reports are obtained when it is carried out within the strict and well-defined good pharmacovigilance procedure framework,

Setting milestones, risk management, allocating employees and money, and dealing with clients and contracts are all examples of clinical project management.

Vaccines are one of the most significant advances in public health, and finding new vaccines continues to be one of the most difficult tasks we face.

Chemical contaminants, bacteria and fungi, and viruses all pose threats to biological and biotechnological goods. Transmission of viral infections is a genuine possibility with these items.

Stability testing is an important aspect of product development and is carried out throughout the life cycle of a product. Stability is part of a biotherapeutic's quality desired product profile, and the results help analysts understand how temperature, relative humidity (RH), light, storage, pH, and other factors affect critical quality attributes (CQAs) of both medicinal ingredients and products.

Internal audits are a necessary for any organization that wishes to last a long time, be successful, and have a good reputation. Internal auditing provides management with a wealth of valuable information by providing an independent and objective review of corporate activities, allowing for unbiased and informed decision-making.

Imagine a company in which everyone can do what they like… no rules, no supervision. Wouldn’t that be a chaos? Corporate governance is important because it encompasses the set of principles, the rules by which all employees should act (policies and procedures, responsibilities by each job position, etc.).

Choosing a pediatrician is one of the most important and challenging decisions you'll make about your child's health. Whether your child has already entered the world or is due any time soon. A pediatrician is a doctor who focuses on children's physical, behavioral, and mental health.

In-house training is a sort of corporate training in which a company's own skills and assets are used. This is a training that the learning for employees led by the company itself. Internal employees and workers are responsible for employee training.

Quality Risk Management (QRM) is the process of identifying, evaluating, and mitigating recognized risks connected with medicines and healthcare goods. An excellent Quality Risk Management programme can be created to reduce risk to a manageable level and deliver high-quality products to protect citizens' health.

A contract is one of the most important components of any industry or corporation, and conducting business or engaging in any form of collaboration without one may be a nightmare for all parties involved.

Nowadays so many firms transitioning to entirely remote work, it's more critical than ever to engage and create a sense of belonging within your team. Nowadays so many firms transitioning to entirely remote work, it's more critical than ever to engage and create a sense of belonging within your team.

When it comes access to funding, Basel 4 will be a game-changer for both banks and corporations. The legislation, which is the finalization of Basel 3 and will take effect in 2023, would reform global bank capital requirements, affecting corporate lending in Europe and the Nordics in particular.

The rapid development of Liquid Chromatography/Mass Spectrometry (LC/MS) technology changed the way bioanalysis was done. Regulated Bioanalysis services are valuable to both the clinical and preclinical phases of studies.

Have you ever wondered how to connect everyone with risks? How to capture the attention of the Board to this important issue?

Internal Auditing in the sense independent assurance and consulting activity performed to add great value and improve an organization’s operations.

The audit in the sense a systematic and independent examination of activities to identify whether the evaluated activities were performed according to decided requirements.

Cyber security is the practice of protecting mobile devices, laptops, servers, computers, networks, electronic systems, etc. from malicious attacks. Understand What is Cybersecurity and Why Cybersecurity Training important for employees.

How would you know if your company is protected from fraud? If you don’t know, let’s tackle fraud risk!

From auditor to auditor: which areas of your company do you audit? The most common answers I’ve heard are two: a) the accounts that are related to money such as banks, petty cash, payments, purchases, etc. and b) the accounts that have a higher balance because when auditing them, a higher amount is being covered.

The simple increase in an employee’s salary is a delicate process called the salary (or pay) review. Salary reviews are usually conducted annually. It is a process whereby employers determine if the employees’ salaries are fair as well as ensuring that salaries are reflecting what the market is offering for similar positions.

Chime, Coinbase, IZettle, MetroBank, Barion all are fintech companies…if carry out due diligence, do you know what to check?

The audit has finished. Now is time to put it right in writing. And for some reason, although this step is the most important -in most cases-, auditors fail to do it right. The top mistakes detected:

Sea level rises, air, water and land pollution, deforestation, resource scarcity…how exposed is your company to climate risk? These factors are affecting any country’s economic activity.

Have you ever wondered how to manage the employees’ performance? What should it be measured and how?

Have you thought about the mental health of your employees? Don’t let them burnout! It’s a fact: most highly engaged employees are exhausted. If this has happened in a normal environment take a moment to think how much this has increased with COVID-19.

For a pay strategy to be effective, it must be integrated with the company’s overall business strategy. Achieving this integration can be difficult. This is because a business strategy can be hard to specify. 

Have you ever wonder about the importance of coaching? No, don’t think about sports; think about coaching in business.

Let’s see: are you sure that your risk-based approach is effective? If you haven’t updated it during the year…if only the Internal Audit talks about risks…or if the budget is not related to it…well, it’s clear: the risk-based approach is not effective.

Which is the on-demand talent that companies need? Coronavirus has also changed the skills we need to work. Here are some...

Originally I was going to write about sustainability concerning employee treatment. But I will save the topic for later because the events of the last couple of weeks are asking for something more up to date. The situation about the coronavirus pandemic has got many connections to the workplace health and safety and to the way we manage it.

Presumed impact of collective experience Thread on safety culture at the workplaces

Having a happy work environment brings many benefits, among them: creativity and innovation increases, as well as productivity, employees are more engaged and your company is more successful. But, how to do it?

In today’s time, it seems job-hopping is a more popular trend than good old loyalty and career ladder climbing within the same organization.

If risks were considered a key part for internal auditors, in 2022 risks are a must. Audits should be risk-based and agile, responding to emerging risks. For this year, top risks include:

Have you heard about behavioral risk? Do you know how it can generate value to the company? Even now regulators are paying attention to it.

If culture eats strategy across all three meals, then the CEO serves those meals.

The world is changing, thus the environment, way to do things, the companies. It’s essential to speak about the audit skills needed for 2022; either the ones you need to update or improve.

Strengthening the corporate culture to make safety a priority value. Employee involvement. Safety motivation. Issues that are being discussed quite often these days.

Is not about the services a bank offers… Neither it’s app. Is about whom are you going to trust your money; and this is linked to the bank’s quality service.

“A woman with a voice is by definition a strong woman. But the search to find that voice can be remarkably difficult. This “voice” is your best tool in the boardroom.” 
Melinda Gates, Co-founder of Bill & Melinda Gates Foundation

‘Women leaders’ and ‘millennials’ are two words which are resonating in our minds.

Do you know which are the female competencies needed to be a leader? Let’s talk about those essentials that you should have:

How to do it? Here are some tips to improve fraud prevention and detection:

Have you heard of the concept of empowering women?

Have you ever wondered how to become a leader? If so, this information is for you.

John Kersey writes on safety technology and related topics for the SHP online publication. He was one of the presenters at the European HSE Forum 4.0 conference in Prague in September 2019 He was acknowledged as one of the Top 5 Speakers at the conference. His presentation covered 5 top safety trends to be aware of. Here he reflects on takeaways since the conference.