The New Normal for Pharma Regulatory

Dr. Prasanna Bangale, Vice President & Head – Global Regulatory Affairs, Global Specialities, Alembic Pharmaceuticals Limited, on invitation from Informa Markets, the organizers of 9th edition of Global Pharma Regulatory Summit, shares pointers on The New Normal for Pharma Regulatory; how this is the best time to generate ideas and develop the best in class, highly productive regulatory team, along with relevant tips on work from home for pharma regulatory professionals.

“At the outset, let me thank Informa Markets for inviting me to express my opinion on current Covid-19 situation with respect to global regulatory affairs. I am delighted to express my personal comments over here. Before I start, I hope all of your families and friends are safe in this tragic unforeseen situation. Please do follow all the necessary guidelines and instructions issued by respective authorities, and contribute in stopping the spread of Covid-19.

Covid-19 will have an impact on many industries and pharma is certainly not an exception. In fact, if you ask me pharma and healthcare will be at the core of it. All other Industries are hoping pharma guys to take lead to fight back this situation. We are likely to see both positive and negative. Let’s talk about something positive which is happening currently, the new synergies between the companies. As an example, Sanofi and GSK are coming together to work on Covid-19 vaccine. Is it not amazing? This is just one example among several others. When most of the companies and even the regulatory authorities are having Covid-19 vaccine and treatment as their priority, which is correct in all the aspects, we regulatory professionals have our own routine agenda to deal with. Such priorities and resource constraints arising due to lockdown situations are certainly likely to delay some normal routine regulatory procedures and processes like submissions and approvals. Which we need to understand and schedule our priorities and timelines accordingly.

As an impact of this situation, I will not be surprised if current regulatory norms and patterns undergo some modification in near future. Hence we need to anticipate such likely changes and be ready with our strategic plans, by taking management into confidence. Let’s wait and watch to see how things shape up in near future.

We have to remember that a smooth sea has never made a skilled sailor. And hence, we must master the skill of converting challenges into opportunities. No doubt Covid-19 is a great learning for all of us and I am confident that we will have better outcomes from this, benefitting our future generations. So stay positive.

Q. How regulatory professionals should manage their day while working from home and how they can make the best use of this situation?

This lockdown and elongated work from home have changed our routine to a great extent teaching us new ways of working. Facing this unimaginable situation is not an easy task. The best way to cope up with this situation, which I am following currently, is to keep the routine same like office, mainly from work timings  perspective. I am currently managing most of my things for global regulatory at different time zones by using man-machine interface at its best.

One has to be a dreamer, and incurable optimist and strongly believe in such situations that every cloud has a silver lining. Because of work from home, we are likely to save some amount of travelling time which is a great add-on. It is a considerable time for people who stay in crowded cities like Mumbai where traffic can be explained as bumper to bumper. And the energy you save due to no travel is of course plus, plus.

Don’t you think this is a great opportunity to do something which we are planning for long, but could not do due to our busy routine? Certainly yes! So let’s talk about what we can do additional as regulated professions while continuing focusing on our business and uninterrupted medicine supplies to our patients, and other routine works.

I suggest, just have a glance at countries which are not priority countries for you. Study their regulations, explore if they are quick wins from regulatory perspective having good business potential. I am sure you will find amazing similarities and differences between their regulations and an opportunity to learn some good practices too.

Keep momentum on by learning new things with the help of online trainings. Is it a good idea to even opt for trainings from other relevant areas such as production, quality assurance, quality control, supply chain? I will even include sales and marketing. This will surely help you to understand your internal customers and their needs better for providing elevated support.

Initiate deliberate dialogues to develop superb rapport with your internal stakeholders. This will help you to identify better ways to work together from organizational point of view, mainly how to deal effectively with post Covid-19 business situation without losing focus on patients and consumers.

Interact and collaborate with federal and state regulators, policy makers, industry associations, and even scientific bodies. Take a chance to get some additional clarifications on matters, which previously you categorize as “important, but not urgent”.

Explore future knowledge exchange opportunity with the stakeholders. Also think about what best way you can contribute in shaping the regulatory environment. I am sure this move of yours will be highly appreciated.

Talk to your industry colleagues and discuss interpretations of existing and new regulations. Trust me, you will gain a lot of knowledge even without losing confidentiality.

Brainstorm and speculate what challenges you are likely to face in the future due to this Covid-19 situation. And be ready with action plan and other necessary requirements as well. For example, you may need to provide different type of non-routine expedited regulatory support to your business to achieve organizational targets. Question is, are you ready for it? Think and be prepared. Rather I would suggest, talk to your leadership team about this proactively and take their suggestions and concurrence.

Human resource is most valuable resource. Trust the principle of unity in diversity, take advantage of the situation and schedule one-on-one dialogues with each of your teammates. Generate ideas and ask for their submissions, which will help you to build the best in class, highly productivity team.

Perform check on the robustness of your systems and processes and also your database maintenance. This you can do it along with your team members. This will also help boosting the innovation.

Speak with your external suppliers, service providers to define your wants and the best way to collaborate with each other in the future post Covid-19 situation. However, while doing all this, do not become aggressive and push others unnecessarily. You never know the situation at others end.

There is a lot you can do with currently available technologies, irrespective of your organization level. So much so that ultimately you will start feeling that, this current lockdown, slow down or restrictive situation is not that long. In fact, you may land up in including many of these activities in your normal routine day to day functioning by making special provisions in your calendar.

Remember, your dream might be closer than you think and hence you need to be prepared from your side always. Just a caution, please do take adequate precautions to maintain confidentiality while using various technological platforms which are available.

On personal front, this is a rare opportunity to venture into areas which you were planning for long. Develop hobbies, keep chatting with school and college friends. Watch movies and dramas at home. Spend quality time with your family and friends.

Keep yourself motivated for the good days, which are going to come soon. I believe it strongly. So, take good care of yourself and see you soon in the next conference, seminar or workshop. Thank you!

Dr. Prasanna Bangale will be speaking at the 9th Annual Global Pharma Regulatory Summit about Changing face of legislation/policy – globalization.



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