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What I’ve learnt from preparing Regulatory Strategies Part 1 – 3

Part 1

WHAT I’VE LEARNT FROM PREPARING REGULATORY STRATEGIES – BEFORE YOU BEGIN….

So you’ve been asked to prepare a regulatory strategy… good for you! You’ve been given an opportunity to contribute at a higher level and demonstrate how you bridge your technical expertise with your organisation’s drivers. Though consider yourself warned – even if you are up for challenges, preparing regulatory strategies may both frustrate and excite you in equal measure. And that’s not all – there’ll likely be an energetic exchange of views following close examination of your strategy.

Having prepared countless Regulatory Strategies, I’ve learned how important it is to consider a few things before putting fingers to keypad. Whether your focus is a niche market or global saturation, a medicine, medical device, novel therapeutic, or a line-extension… a few early considerations can be invaluable.

In my experience, overuse of technical jargon, misaligned assumptions and missed opportunities to challenge assumptions are all too-common findings in Regulatory Strategies. Embarking on a detailed investigation of Regulatory pathways when a short verbal overview at the next project meeting suffices is another one. As is confusing strategy (the why and the how behind the proposed approach) with a plan (detailed milestones).

Your objective in preparing a regulatory strategy is to provide strategic advice to your organization, so remember to keep in check your personal views about the ask and to shift focus away from what you know to what your audience wants to know – this is the essence of strategic regulatory planning.

“…there’ll likely be an energetic exchange of views following close examination of your strategy”

Here are a few more tips to get you going…

Five questions to consider prior to preparing a regulatory strategy

How does the particular initiative fulfil the organisational strategy?
What deliverable is expected from you, and when is it due?
Who is the audience?
What assumptions or constraints are relevant, and which might be challenged?
What is the risk appetite for this particular initiative?

When done right, regulatory strategy development offers a unique opportunity to align scientific, business, and compliance goals from the outset.

Part 2

What I’ve learnt from preparing Regulatory Strategies – Now that you’ve started….

So now you really are ready to write that regulatory strategy or to present a verbal overview at your next meeting. If you missed my previous tips to help you be ready, refer to my previous article What I’ve learnt from preparing Regulatory Strategies… before you begin.

If you are lucky, you’ll have a clear scope to workshop. Though often your ask will be something broader like identifying the most attractive markets for a new product pipeline. Either way, you are expected to champion the organisational objective and craft a competitive regulatory strategy. Balancing the seemingly conflicting needs of your organization with those of the Regulator (or multiple Regulators, as is often the case) requires both Regulatory prowess and alignment to your organisational drivers.

But how can you do this when faced with an initiative that seems just plain crazy? Try playing in the space of possibilities – for example, a June submission date might be achievable if the Clinical Study Report were to be available earlier. Remember also to differentiate between laws and guidance and watch out for the objective behind the objective – for example, sometimes Regulatory approval is a more pertinent milestone than the Regulatory filing date.

Buzzwords like options, risks, costs, and time have important roles in good Regulatory Strategies – use them. Quantify risk and benefit (e.g. in terms of cost, time etc) and capture key non-direct costs such as resource impact. Consult your network, both internal and external – of course, without disclosing sensitive information to external contacts – you may be surprised at the intelligence you gain.

It may sound counterintuitive but knowing when to stop researching is fundamental, there is usually an opportunity to further dissect your strategy following initial discussion. Keep your regulatory strategy succinct and leave details for appendices or verbal discussion.

Finally, organisational drivers and Regulatory trends do evolve, so don’t be afraid to revise your strategy.

“Quantify risk and benefit”

Here are a few more tips for you …

Five questions to consider whilst preparing a regulatory strategy

What is in/out of scope?
How might Regulatory or organisational assumptions be explored?
What sources of Regulatory Intelligence might be helpful?
Who are the key stakeholders
What Regulatory expertise might be helpful to engage?

In some cases, bringing in regulatory affairs consulting expertise can help you validate your assumptions and refine your recommendations with deeper market insight.

Part 3

What I’ve learnt from preparing Regulatory Strategies – Making the next one even better…

Relief! Your regulatory strategy is complete. Now for the feedback, are you ready for it?

For my tips on preparing Regulatory Strategies, refer to my previous articles What I’ve learnt from preparing Regulatory Strategies… before you begin, and What I’ve learnt from preparing Regulatory Strategies… Now that you’ve started.

Ultimately, the success of your regulatory strategy is determined not by you, and not even by your target Regulator(s), but by your organisation. So let’s take a look at three typical reactions from your organisational audience, and how you might reflect on these to make your next strategy even better.

Scenario 1 – your proposed approach was met with an instantaneous and boisterous objection

Were there shortcomings in your Regulatory expertise? Whilst external support may plug such a gap, do check first for any untapped knowledge within your organisation or external network (this one with caution).

Ask yourself, were you blindsided by the reaction your regulatory strategy received? If so, then it is likely your audience was blindsided by your approach. Stakeholder engagement, particularly when presenting controversial advice, is invaluable. Next time, pay closer consideration to who might have the biggest objection, and how you might engage with them prior to delivering your strategy. Often, bold reactions are not due to regulatory insufficiencies.

Scenario 2 – your documented regulatory strategy was barely read, and instead you were asked to provide a verbal summary

Ask for feedback. Was it too long, too complex? Were key points lost in the technical blur? Would a verbal summary or a three-slide PowerPoint have sufficed, at least initially?

Scenario 3 – the risks and challenges you raised were largely ignored

Did your strategy highlight these sufficiently? If not, then find another way to do so. If, however, risks and challenges did receive the right level of attention, then perhaps they weren’t ignored. Perhaps they were simply accepted as such by those in your organisation with authority to do so, in which case, accept it and move on.

“Ultimately, the success of your regulatory strategy is determined … by your organisational audience”

Expect that an important organisational objective will elicit passionate and lively discussion – that’s why you’ve been tasked with developing a regulatory strategy

Five questions to consider as you reflect upon your regulatory strategy

How was my regulatory strategy received?
What assumptions were missed or not challenged?
Were risks and benefits quantified?
How could stakeholder engagement be improved?
How could the clarity of my regulatory strategy be improved?

Robust regulatory planning should be iterative. Every strategy is an opportunity to improve alignment, engagement, and value delivery.

For a complimentary regulatory strategy starter tip discussion or regulatory strategy assessment, email me on mnteris@enimeraregsplus.com.au