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How to talk to Regulatory Affairs Authorities?

Having a teleconference or a face-to-face meeting with Regulatory Affairs Authorities is business-as-usual in our Regulatory Affairs world. Still, I often get surprised how many people underestimate an overall process of preparation, conduct and closing of interactions with Regulatory Affairs Authorities.

There are some simple easy to remember rules we learned over the years talking to Regulatory Affairs Authorities that proved to be extremely useful to team members attending any Regulatory meeting. We often clearly outline these rules and repeat them continuously throughout the preparatory process for any Regulatory Affairs Authority meeting.

1. Be polite and respectful

Yes, you might realize during the meeting that someone from the Regulatory Authority’s team didn’t understand your topic, might be stricter than you expected or doesn’t want to accept your arguments.

Your job is to manage the situation respectfully and politely. Try to explain one more time, bring up new arguments (if available as a contingency plan) or simply thank them for their opinion (if you see that their position is firm and you don’t have any further data to support your position).

2. Be honest

Always be honest.

If you don’t have the data or information they requested- honestly say so and promise to check with your team after the meeting if, when and how the requested information might be available.

If your data is not favorable, you should not hide it. It is probably not a black-and-white situation and these data are probably the reason you are talking to Regulatory Affairs Authorities. The best way is to present the situation as it is together with the potential solution and ask for Authority’s opinion.

3. Be straightforward

Regulatory Affairs Authority meetings are limited in duration- usually 1 hour. Out of it, your team will usually have 15 -20 minutes to present discussion points no matter how complicated the topics are. So use them wisely.

That first “final draft” PowerPoint presentation of 50 slides will be quickly cut to 25 slides and then one more time to 10 slides and the remaining 40 slides will be put as so called “back-up slides”.

Authorities have prepared for a meeting with you. This means that they know your product, issues under discussion and they already agreed internally about their position together with arguments backing it up. Your job is to present something new in this presentation or to present the situation in a new light that will help your case. Focus on that, trim the rest.

4. Know your task and stick to it

Regulatory Affairs team is carefully preparing for any Regulatory Affairs Authority meeting. Every person attending the meeting will have his or her task and exact timing when to perform it- we expect that this be followed during the meeting.

During the rehearsal sessions these agreements are further fine-tuned and adjusted as needed.

Any deviation from the schedule can quickly confuse the team leading to the situation where the most important topics don’t get discussed (due to the time constraints) which is always a bad outcome. This leads us to the next point of having one leading spokesperson from your side who can identify changes in schedule and quickly react.

5. Designate one spokesperson

It is in your favor to have everything you wish covered during the meeting. Therefore, it is extremely important that one moderator from your side keeps a watchful eye on time spent on various discussions and to make sure you cover everything.

In addition, the moderator also takes all Authority questions first and calls out for Subject Matter Expert to respond. The moderator is usually a Regulatory Affairs person.

6. Expect the Unexpected

There is a reasonable chance you could predict approximately 70% questions you might receive from Regulatory Affairs Authorities, simply because you know your product’s data inside-out and therefore know its strengths and weaknesses. However, you will not be able to predict all of the questions.

Therefore, it is important to be able to handle the situation if you don’t know the answer right away. General strategies include providing statements similar to “Thank you for your question. We will check our data/database/CRFs/etc. and provide the feedback as soon as possible after the meeting.” Don’t commit to any timelines if not explicitly asked by the Authority because you simply might not know on the spot how much time is needed to extract, sort or present the requested data. If asked when you could provide the information respond that you will check with the team and will inform the Authority about the timing in 1-2 days.

Of course, you should be swift in providing any additional information after the meeting.

Know some other simple rules for talking to Regulatory Affairs Authorities?

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