Gergana Semova: bridging science and market
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Gergana Semova: bridging science and market

Vagabond Magazine*: The General Manager of PharmDedict knows the ins and outs of drug regulations

Drugs in the pharmacies have gone a long way before reaching us and improving our health. To a significant extent, this is thanks to the work of companies such as PharmDedict. Since 2007, the consultancy has connected drug manufacturers and distributors with Regulatory Authorities in EU to ease the process of introducing new drugs on the local market. As co-founder of PharmDedict and its General Manager, Gergana Semova is responsible for the company’s successes and future projects. Her competencies are in the field of business development, product licensing, project management and regulatory affairs.

What was the main thing that you wanted to achieve when you co-founded PharmDedict? Did you achieve it?

Our goal was to create a company that would offer specialized expert service for a crucial component in the process of providing medicinal products for human use that is often not understood well and is underestimated by the participants in the drugs supply chain. Drug regulatory affairs are the link that bridges science and market in developing new molecules or implementation of generic drugs, which are a more affordable alternative to the original medicinal products, after the expiration of their data exclusivity and patent protection.

A pharmaceutical product can reach the patient only when it is efficient and safe, and it was evaluated and authorized for use by the competent authority. In the EU, this is the European Medicines Agency and the national drug agencies in the relevant member states, like the Bulgarian Drug Agency in Bulgaria. Pharmaceutical companies which develop and market medicinal products for human use may place the product on the market only after it was assessed and authorized for use by the respective competent authority. Regulatory consultancy companies such as PharmDedict bridge pharma manufacturers with regulatory authorities to support both of them during the assessment process for a timely authorization in favour of the patient. Regulatory affairs is a complex field and our aim is on one hand to help our clients during the assessment process, and on the other to support the regulator with the complete and compliant documentation. Our company is successfully operating for 17 years in the EU, a proof that we achieved our goal.

Why does the market need companies like yours?

The reasons were one when we founded PharmDedict and different in recent years, but the need for companies like ours remains constant.

Professionals who want to pursue a career in drug regulatory affairs should be aware that this field requires specific education and expertise, specific personal traits, unwavering dedication and efforts to continue learning. It takes years of hard work to become an expert. In addition, the work is very demanding, with high volumes of highly responsible tasks performed under stress and in tight deadlines. Often, even large pharmaceutical companies with their own regulatory departments need a specialised service provider to meet the huge volume of work in time or to add missing expertise. Another group of companies entirely lack such departments as they prioritise their financial resources for other departments in the organisation.

Which of your leadership qualities helped for the success of PharmDedict?

Successful leaders combine top expertise and the capability to inspire the others to follow them in their journey towards achieving the set goals. There are many examples of exceptional professionals who fail as leaders of companies and teams, but also of many inspiring people incapable of creating a stable company.

The high level of expertise requires dedication and hard work that start at school and continue through one’s entire professional life. You cannot analyze the environment and processes and make the right decisions if you do not know your field in detail.

We all have qualities that we improve in communication with others and by gaining more life experience and wisdom. Setting a personal example and ethical values are also crucial. The qualities that helped me through the years are my decisiveness, perseverance and eagerness to face new hardships and challenges. In a complex business environment each team should be aware that in hard moments there is someone to take full responsibility and set the general direction. This is something that requires decisiveness and bravery.

What was the most important leader decision that you had to make with PharmDedict?

For me, all decisions are equally important because they are all connected; each of them affects the entire managerial process. I make some decisions rationally, but others entirely on intuition. I think that the most important leader decisions should be made as a combination of the two.

What is the most important thing that companies should know about the Bulgarian pharmaceutical market?

The Bulgarian pharmaceutical market developed significantly in the past decade both as volume and sustainability and predictability. Bulgarian patients have access to the most advanced therapies for grave socially important diseases only 2 years after their approval by the European Commission. This is not that long when compared to the entire approval process. On the background of the whole healthcare sector in Bulgaria, the pharmaceutical market is arguably the best organised. Despite this, taking difficult political and business decisions is often required. In such moments the only thing that we can do is to ask ourselves: “Will this benefit the patients and the society in general?”. If the answer is positive the solution is clear!

How do you balance between your professional and personal life?

I know when to stop. I manage to focus and prioritise things in my life. I believe that it is easy to find the balance when you are happy and love what you do both at your workplace and outside of it, with your loved ones.

*Original publication: Vagabond Magazine