CHMP opinion meetings and a snack with cheese, sausage and shoots — all in a day's work for a project manager in Team Global Regulatory Affairs (GRA). Team leader Christoph Buchfelder reflects on his ten years of experience in project management at mt-g.
I wake up in the morning and go about my usual routine. Breakfast is normally fresh bread from the bakery next door, spread with butter and topped with sausage and cheese. Today, I even have a special topping of homegrown shoots. A slice of bread and butter with shoots — delicious! Then I drink my coffee — with just milk, no sugar and then I'm all set for a new working day!
I look at my calendar. It's going to be another exciting week for Team Global Regulatory Affairs, with lots of different projects.
Is there anything special on the agenda?
There certainly is — the CHMP opinion meeting is this week. CHMP (Committee for Medicinal Products for Human Use) opinion meetings are a highlight for GRA. Once a month EMA’S CHMP hosts a meeting on its assessments of new medicinal products. We have already received advance notification on a few projects from our customers.
I like it best that way, because then we can get everything planned within the team and reserve capacity with our translators accordingly.
As with almost any opinion, there are sure to be surprises, this time too in the form of unexpected projects. But that doesn't really worry me.
Our Team Global Regulatory Affairs is extremely capable. It is made up of project managers with years of experience behind them. Our internal quality assurance team,are likewise very familiar with all the regulations and requirements for new drugs. Nothing can go wrong, as we work in close collaboration with one another – as colleagues who are also friends. Teamwork and mutual support are invaluable, particularly in stressful situations where there are multiple projects in progress at the same time.
Of course there are stressful situations, but the most important thing is to keep a cool head.
What exactly causes this stress?
One example, as I mentioned earlier, is when unexpected projects are submitted for an opinion, throwing our planning into disarray. But that's not too much of an issue for us — we're able to take those kinds of situations in our stride. We're very flexible.
We have never delivered a project late in the last 24 years, since our company has been in business, and there is a reason behind this. Our customers have always been able to meet the timelines stipulated by the authorities. And this will not change in the future.
And now you're thinking: "Congratulations! But surely that's your job?! Are you expecting a compliment now??"
Erm no, that won't be necessary; we know that we're good at what we do – and our customers know it too.
"Well, I'll have to take your word for it", I hear you say.
Not at all! If you compare notes with your contacts on social media, I am sure that at least one, if not several of your contacts use and greatly value the services of mt-g. And that doesn't apply only to Regulatory Affairs, but also to other translation projects.
If you were to ask me what I see as the perfect workflow for an opinion project, it would look something like this:
1. We are informed that a product has been submitted for an opinion.
As you would expect, the marketing authorization holder often has no control over the exact timing of the final CHMP outcome. Sometimes the texts are available on a Thursday, sometimes not until Friday. On a rare occasion even on a Saturday!
2. We are informed of the approximate range of the expected changes.
Where possible, the changes to the text should not be excessive; this helps to ensure that the changes can be translated into the 24 language versions within the +5 days. Also need Irish as a 25th language? No problem. We can do that.
You know as well as I do: The +5 days includes the weekend, during which you can also rely on our support.
If the changes to the source text are very extensive, a pre-opinion update would be advisable.
3. Let us know if you also require support with the linguistic comments from the national competent authorities. We are more than happy to help you with this too.
4. Finally, do you also require clean Word and clean PDF versions in accordance with the EMA's PDF guidelines? No problem. We can also do that.
And what about when you yourself get a "surprise" project? Either as part of an opinion or within the regulatory lifecycle? Another department within your company calls you unexpectedly and needs everything right now. Sound familiar?
There's no need to panic! We are familiar with these situations, and we know what needs to be done. Simply give us a call or drop us an email. Together we will make sure your project is a success.
Speaking of working "together" — mt-g also offers a regulatory labeling service together with our partner.
This means that, in addition to supporting you in translating and updating your products, we also assist you in creating and updating your source texts. Furthermore, we can communicate with all relevant authorities on your behalf. Sound good? We think so too!
I have experienced so much in the ten years that I have been working as a project manager in Global Regulatory Affairs — both good and bad.
In our professional lives as well as our private lives, we want a partner by our side whom we can rely on 100% and who treats us as an equal.
While we have no intention of interfering in your private life, when it comes to your professional life, we are the right partner for you. Try us and see.
mt-g.com