The Organization for Professionals in Regulatory Affairs (TOPRA) is a non-profit, non-political organization that seeks to advance the status of the regulatory profession through education and the provision of information to its members. Its members are drawn from industry, regulatory agencies and consultancies from over 40 countries. Pharm. Exec. Europe (PEE) spoke to TOPRA’s president-elect, Dr Zubair Hussain, head of regulatory affairs for Pfizer UK and Ireland, about what he sees as pharma’s key regulatory challenges for 2010 and beyond.

PEE: What do you see as the key regulatory affairs (RA) challenges for 2010?

ZH: Understanding the changing regulatory and health technology environment can help companies to secure regulatory/pricing approval as speedily as possible for new products. Agreement on the EU pharmaceutical package (pharmacovigilance, counterfeits and patient information, and achieving operational excellence in compliance with limited resources available to companies in this economic climate, particularly for SMEs.

What do you see as the TOPRA priorities for your upcoming tenure as president?

I will be delivering an operational plan that helps meet the longer-term strategy of TOPRA. The strategic direction of TOPRA is going to be debated this month and agreed by September 2010. Although the strategy reviewed each year many elements will be enduring for 2­–3 years. Clear themes likely to feature are

• a vision of how to develop as a professional body for RA
• improving education and training for members and regulators
• launching TOPRA publishing, build on providing networking opportunities
• maximising RA membership in developing market
• meeting our financial obligations to members
• improving our offerings and the efficiency of our operations in delivering the many benefits to our broad customer base.

What do you think needs to be done to increase the profile and perceived value of RA in the pharma industry?

We need to consolidate our strength as regulatory professionals in two ways. First, we need to become business leaders who are clear business partners internally within our organisations, whilst educating that a clear commitment to operational excellence in compliance is a competitive advantage. Technical skills traditionally afforded to RA are necessary but no longer sufficient for success in the future. Communication skills and business acumen are key in developing fruitful relations with business colleagues, who need to be clearly given the values of regulatory interventions that grow and protect the business.

Second, we need to build relationships on trust and transparency. Embracing the objectives of regulators and the patient is vital.

Do you think increasing globalization in the pharmaceutical industry will lead to more regulatory harmony, particularly between Europe and the US?

We all hope that increasing harmonization can help improve delivery of innovative medicines to the patient for the future, as an industry we are prepared for this and would like to move faster than perhaps the regulatory processes and legislation will allow. Steady steps in the right direction continue, but there is a great deal more debate to be heard before we get there. Collaboration between the regulators in the US and EU is increasing however the decisions still remain separate based on medical practice and benefit/risk calculations in specific populations.

The role of national competent authorities (NCAs) in Europe will still continue in my view in the next 5­–10 years. Scientific bodies in Europe still need national experts to conduct the review for new medicines. This improves the scientific network in EU also. Although regulating medicines has to do with the free market it also is of public health concern and NCAs are still accountable to local ministers and thus can still make urgent decisions based on national interest. It’s difficult to see pure centralisation of all healthcare professionals in all countries.

Are you optimistic that the EU pharmaceutical package will have a positive effect on anti-counterfeiting and pharmacovigilance measures across Europe?

New legislative proposals are going through the European Commission that I believe will help improve the integrity of the supply chain. Industry has assessed the potential impact of this legislation and although this is still being discussed we are hopeful that the feedback to consultations on these proposals will result in improvements that will help protect patients.

We all need to be abreast of pharmacovigilance changes, and appropriate risk management plans for our products. There is a significant opportunity for colleagues outside of RA and safety to learn and understand these requirements better that help protect patients and improve transparency.  All pharmaceutical companies are inspected on pharmacovigilance as well as other regulatory activities such as good clinical practice and good manufacturing practice. It is increasingly important for marketing and sales colleagues to be aware of these regulatory changes: why they have been put in place, what the implications are for them, and to keep up to date on their training.