10 tips for successful modern signatories
The term “gate-keeper” implies only signatories are concerned with compliance with the ABPI Code of Practice, so we prefer the term “goalkeeper”; if the rest of the team are doing a poor job, many balls are going to come their way, and probability dictates that one or two are bound to go in and result in a breach of the Code. However, if the team are supportive, cohesive and communicate, then the goalkeeper has a good chance of focussing on and saving one or two of those balls.
We can all identify the old-school signatory — headphones in, reject without reason, create an environment of fear… We strongly advocate that a modern signatory is approachable, constructive and commercially-astute, and works with their team to achieve creative and compliant outputs.
Indeed, the Arsenal goalkeeper, Petr Cech is well-known for speaking five languages and communicating with his team in their own tongue in order to get the most out of them, resulting in one of the cleanest sheets.
Below are our top 10 tips to working effectively as a modern signatory:
Be part of the cross-functional team from the start
- Ensure the whole team appreciates the accountability associated with such a senior position
- Avoid the development of non-compliant ideas from the outset
- Set clear expectations regarding standards (format, layout, referencing etc.)
- Know the deadlines, to allow for proper planning
- Avoid being ‘squeezed’ in the final stage of the project – certifying just before use does not make for job satisfaction or confident compliance!
Encourage team communication
- Signatories should communicate their decisions, with the pros and cons that got them there
- Be confident asking for good quality information required to make a robust decision
- If the rest of the team proactively provide the information surrounding the context of an item or activity, it makes the signatory’s job more efficient
Stay abreast of PMCPA case rulings and guidance
- Published cases provide an insight into the way the PMCPA interpret the requirements of the Code; look out for cases involving competitors and your companies’ therapy areas
- Attend regular case review meetings that may be offered by your company – both the Code and learning from cases evolve over time
Attend signatory meetings
- Allows best-practice discussion with more experienced colleagues
- Ensures all company signatories are consistent in their approach and in line with company SOPs
- This can help avoid ‘signatory shopping’ where a signatory “happy” to sign off may be used in place of others who may voice concerns
Be aware of your own weaknesses and review style
- Every signatory, whether experienced or new will benefit from seeking others within the team or company who can provide expertise and knowledge and allow you to broaden your thinking
- Signatories that are inclined towards more “big-picture” review, will work best when a reviewer on the approval team is “detail-oriented” – this partnership is a true reflection of what copy approval is intended to achieve
Immerse yourself in the role
- Try to gain as much experience in as many different types of items as possible – with experience comes the ability to take considered risks and make pragmatic decisions, whilst never compromising on patient safety
- For example, certifying joint working projects for the first time need not be a challenge if previous projects are reviewed, the latest guidance is checked, and recent cases are considered
Do not be afraid to challenge on compliance grounds
- Reassurance that “everyone else is doing this” does not make an activity right but it can be hard to stand your ground in the face of internal pressure
- Similarly, fear that “no one else is doing this” does not make an activity wrong and it is worth conducting a risk-assessment to develop strategies to reduce the concerns
- Know what the possible sanctions might be if that risk is taken and you are found in breach of the Code
Challenge whether the item requires certification
- On occasion, items that do not need certification will head your way – whilst the easiest option would be just to go ahead and sign them, consider the SOP position and adhere to that
- This is an opportunity to upskill originators in the correct route of approval
Engage in being SOP stakeholders
- Whilst there is never enough time to do the day job, being asked to consult on company SOPs is a real opportunity to suggest streamlined ways of working when it comes to signatory workload (time will be freed for more appropriate jobs or that invaluable case reading!)
- Embrace the short-term pain for the long-term gain and consider the following questions:
- Why are we certifying items that require examination under the Code?
- Why does our examination process involve signatories?
- Why are we not using appropriately qualified persons to check hard copy items?
- Why are we still using signatories to certify overseas meeting arrangements?
- How can we better support originators and reviewers to reduce signatories’ workloads?
Practice being complaint leads
- Signatories are often asked to be leads in the event of inter-company dialogue or a PMCPA complaint. Should the wrong strategy be employed, or the response naively constructed, the consequences can be disastrous for the company.
- The approval strategy should be identical to the defence strategy and should be noted as such in the approval system
- Furthermore, war games can help the company predict complaints that might be received for novel or innovative campaigns, and therefore reduce time spent in the event a response is needed
These tips can help you develop some of the key skills of being a modern signatory, as well as upskill those that work with you and ultimately improve outputs.
By bringing these tips into everyday practice, as a signatory you too can save fewer goals and gain one of the cleanest sheets.
About the author
Dr Rina Newton is managing director of CompliMed. Rina has more than 20 years’ experience working with the ABPI Code of Practice – as originator, reviewer, medical & non-medical final signatory and auditor – so is well-versed with the practical challenges in applying the Code to everyday situations.