Get To Know Our Experts – Brian Edwards

In this article, we shine the spotlight on Dr. Brian Edwards, one of our most seasoned Principal Consultants who has been with NDA since 2007. He specialises in Pharmacovigilance, quality management, and all aspects of safety compliance, risk management, QPPV services, and clinical trial safety. 


Throughout Brian’s career, he has seen every angle of the area, clinical, academic, industry, and regulatory. In October 2020, he was awarded a Fellowship of ISoP (International Society of Pharmacovigilance) for his contribution over many years.

The fellowship with ISoP, what does that mean to you?

“Being a registered physician, putting patients’ interest first has always been my top priority. This global organization provides fabulous opportunities for discussions with thought leaders around the world on how to develop pharmacovigilance.

We think globally but act locally by encouraging and mobilising talent and volunteers at a national level. This is a great opportunity to understand the way pharmacovigilance is evolving and adapting in many different countries throughout the world, scientifically, culturally, and organizationally. We are giving everyone a voice”.

What are the major improvements you have seen in medical safety during these last 20 years?

“What is interesting is that there are novel, innovative solutions coming. They are coming from developing countries because they are often operating with a blank sheet of paper.

Developing countries have to be much more targeted and focused on their efforts and they can come up with alternative and more efficient ways of interacting with patients in order to help them manage the risk of medicines”.

What do you consider the major hurdles for reducing human errors today?

“First of all, it is leadership. If it is not clear within the system who is accountable, it leads to a dangerous blame culture. So, system design is very important in this whole topic.

Then there is communication with artificial man-made barriers stopping sectors of society from talking to each other. We get more and more guidelines, but you never make a system safer by making it more complex”.

“The whole industry should be talking about systems and solutions, pharma sector has far too little interest in evaluating what works well and learning from it.

We all have social responsibility at our core, even allowing for proprietary processes as we are all running a business. If we can come together and talk about systems solutions, then we can move novel solutions forward.

What is your opinion of an ideal state of medical safety?

“Organisational effectiveness, I would say. Enhancing the understanding of all the factors that influence human performance and having a system where people are motivated to collaborate rather than work in silos.

These artificial divisions have been created over time for good reasons, but they do not solve the problems.

If we take ATMPs for instance, where GMP, GCP, and PV all run into one another, the idea of keeping it all separate is extremely artificial and it hinders innovation. Here the pharmaceutical industry can learn from other sectors. Because there has been no joined-up thinking we cannot move on from talking about safety – it should be implicit within any discussion of organizational effectiveness”.

How do you mean? Can you give an example?

“Well, from my experience I find that most urgent situations for the clients have to do with some kind of safety concern. It might be organizational issues, how to handle unexpectedly difficult data that is not immediately recognized as a safety issue.

Safety is ultimately all about human performance and that is where we can help. It could be that you have a product that does not fit the conventional pharmaceutical legislation, that requires completely innovative thinking. That is the nature of innovation”.

Which advantages have your combining your job at NDA with voluntary work provided?

“Because we are a consultancy firm, we like the most challenging products from our clients.  This sets an intellectual culture for finding original ideas and solutions, to think outside the box. So, working in that environment has helped me to cultivate these ideas which you can then use in the professional voluntary environment.”

“By turning over the table and volunteering for a very forward-thinking international organization, has made me more aware of what is new and that gives me a lot of confidence when expressing my opinion. I know that I am up to date with the current best practices and that is what I can offer to NDA’s clients”.

What would you say, in your personality, is your best asset for this kind of work?

“I always stress the importance of quality system design and the process, but actually I work best when there is no process.

For me, I just love to be thrown into the deep end and entangle whatever problem may have occurred for the client. It is very rewarding. If I encounter a barrier, I never see it as a fact of life.

If something needs to be done to manage the safety of medicine, well, then you have to tackle it. You must think of ways of doing it and this usually means dealing with human factors.

Are you looking for deep regulatory and strategic knowledge to support your drug development program? Email us at info@ndareg.com to get in touch.

Remote audits – The new normal

By: Helen Kargaryani, Global Head of Quality at NDA Group.

In this whitepaper, Helen provides tips and good practices for remote audits as an alternative method to conducting traditional on-site audit.


The COVID19 pandemic is presenting unprecedented challenges to healthcare, the pharmaceutical industry’s supply chain and the ways in which companies operate “business as usual”. Quality and compliance activities have been particularly affected, areas that are crucial to ensure the long-term safety and efficacy of treatments.

Quality audits and inspections are essential aspects of the checks and balances in a pharmaceutical Quality Management System (QMS). With new guidance’s, constrained travel and limited access to buildings, suppliers, records and people, manufacturer, regulatory and quality personnel must now explore methods and techniques to evaluate quality and compliance in light of these restrictions. To meet these challenges, regulatory agencies and companies alike are adapting to the situation, relying heavily on remote mechanisms to continue delivering lifesaving medicines and products globally.

In this whitepaper, we will provide tips and good practices for remote audits as an alternative method to conducting traditional on-site audit. This paper will also cover circumstances in which remote audits may be necessary and preferable to an on-site audit. Furthermore, we will discuss potential challenges and benefits when auditing remotely and how to adapt your processes and systems to prepare your company for remote audits.

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Contact us to learn more about how our integrated team can provide advice and support into your drug development plan.