Ok, so it came as no surprise, ANVISA “suspended” their serialisation dates for RDC-54/2013. Indications from local regulatory contacts indicate a delay of 3 years is on the cards, but who knows.
Feeling of déjà vu anyone? This certainly isn’t our first time around this particular revolving door at Be4ward. For serialisation teams this sort of late-in-the-day significant delay poses a number of issues, including:
- In the short term, how to cleanly shut down activity in a way that can be effectively picked up later
- Establishing a way to maintain local relationships with their Brazil team in the interim
- Redeploying individuals who were involved in Brazil
- Dealing with the potential senior management loss of credibility risk that may make timely funding decisions even harder to get approved in future, for Brazil or any other upcoming legislation
I was listening to a Ted talk (highly recommended if you have not discovered it www.ted.com) last week on the subject of motivation and it is very relevant to another dimension that team’s must consider. This sort of delay will no doubt put some team members in the position of having done a lot of work for Brazil, perhaps for the second time, that could easily be seen as for nothing. However well teams have positioned the risk of this delay to prepare the team, it still potentially leaves individuals feeling they have done work for nothing, which is very demotivating and should not be underestimated. The Ted speaker suggested that management need to think hard about ways to help team members see the positive in the work they have done in this sort of situation to ensure their motivation stays high. Any thoughts on how team’s would do this would be great.
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