Preparedness tips for regulatory professionals


Abhishek Sinha, Head Regulatory, Advanz Pharma, shares his views on the best practices to improve functional expertise and how one can be business ready during and after the Covid-19 lockdown period. 

“These are of course unprecedented times, so it’s very vital we follow government and healthcare service guidelines to protect ourselves, our families and the wider community. I recognize this is difficult time for all of us, but I would encourage everyone to remain optimistic, stay indoors, stay connected, using the amazing technology that’s available nowadays and most importantly, be there for each other.

I am a firm believer that with every adversity comes opportunity and very optimistic that using this opportunity you can use this period to invest in yourselves and think about how you can shape up your future. Here are some tips I would like to suggest to all of you:

Maintain a healthy approach: Stick to your normal timetable, watch your diet, and try to get some exercise done indoors given the current lockdown situation.

Upskill yourself: This is a good time to be either learning new skill sets, or refresh or upgrade the existing ones. With most of us currently working from home, use the time you would have spent commuting. Try to flexibly manage your time. There are plenty of online resources and platforms available on the internet both for technical and soft skills.

For example in my organization, Advanz Pharma, we have access to learning platforms which I can share with my team and encourage my team to make most of it during this period.

Grow your contact base: You can use this time to try to make new contacts either by sharing experiences on discussion groups or looking for opportunities to collaborate across the industry and peer forums. Informa is a very good example which allows you to reach out to a broader, wider community and share your experience with everyone.

Work on your leadership qualities: You may or may not be in a leadership role, but it is never too early to start honing leadership qualities which will go a long way in defining you as an individual and hope you will be able to use some of these qualities in your future endeavors.

Q. What are the best practices to improve functional expertise?

With Covid-19 situation, most regulatory authorities have started issuing advisories about ways of working, taking flexible approaches wherever necessary.  Being in regulatory affairs we have to watch this space very carefully. One of our important responsibilities will be to ensure that our internal stakeholders are made aware of all such changes. The changes that impact them.

It’s also critical that we work very closely with our commercial supply chain colleagues, with our external partners, and with regulatory authorities to ensure that the continuity of essential medicines is maintained all the time.  We continue to anticipate challenges and also fulfill all our regulatory obligations. So I think cross-functional team working is going to be a very important in these days.

Q. How can you be business ready during the lockdown period?

The best way would be to protect yourself and your family by following all the guidelines issued by your local authorities. Any business is run by people, and hence it is paramount that everyone is very mindful of the precautions that the local authorities have lain down and take it very seriously.

This is our philosophy at Advanz Pharma where we have moved to home working almost a month ago. I think in these unprecedented times we should make extra effort to reach out to our teams, our stakeholders and try to be supportive as much as possible.

As always, one of our important priorities at Advanz Pharma has always been patient access to critical medicines. So it’s all about taking necessary steps to make sure we continue to ensure supply essential medicines particularly for those which we are the sole suppliers.

Prioritization is another important thing in these pressing times, which will be very important. You need to prioritize your work properly, what’s more important for you. You have to work very closely with your manufacturing facility, your supply chain teams to look at the potential impact owing to the limited supply capabilities of maybe some of your API suppliers or some of your manufacturers because of their locations where they are based out of.

Many regulatory authorities are coming out with regulatory flexibilities. They know they are expediting regulatory assessments in many cases if things are patient critical. They are bringing in reduced additional testing criteria just to facilitate importation, etc. I think regulatory can play a key role in the decision-making process by making sure that the stakeholders are aware of these options which are available.

Q. What must a regulatory professional expect once lockdown opens up?

I think we are all looking forward to coming back to our offices and start working from our offices, getting reunited with our colleagues. I believe we will see a greater degree of bonding across all the teams as we come across the other side of the situation. I am very optimistic about the fact that we are going to be a more stronger, a more collaborative and more grittier team in the long run, courtesy this situation.



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9th Annual Global Pharma Regulatory Summit

Scheduled on 19-21 August, 2020, the 9th edition of Global Pharma Regulatory Summit, organized by CPhI Conferences and Informa Markets, will witness a  gathering of senior leaders and experts of regulatory affairs, compliances, quality assurance and policy makers to discuss and share their perspectives on current trends and challenges in the global regulatory landscape. The themes are designed to inspire and enable the brilliant minds from across the pharma ecosystem to come together to examine, discuss and debate how to improve the regulatory system and lower the challenges associated. To know more about the summit’s detailed agenda and speaker line-up visit:

Abhishek Sinha, Head Regulatory, Advanz Pharma, will be speaking at the 9th Annual Global Pharma Regulatory Summit about Changing face of legislation/ policy – globalization.