As we begin to wrap up the year and look ahead to 2021, it is critical to prepare your team for what is coming in the weeks and months that lay ahead. Preparation and preparedness are key to ensuring regulatory success at any point, but especially as we approach a new year.
It is no secret that 2020 has been a very different, and challenging year. Many unexpected changes and unknowns that have been thrown at us, derailing any plan and preparation that was done at this time last year. With that in mind, it is essential to develop a plan and prepare for the road ahead, but if we have learned anything this year, we need to make sure these plans are nimble and adaptable.
To assist you in the preparation process, we have compiled a list of five things to consider as you prepare for 2021.
As the year has unfolded, it has become abundantly clear that COVID-19 is not going anywhere anytime soon. With that being said, the pandemic will continue to have a significant impact on product development in 2021. Specific impacts that may be experienced due to the global pandemic include:
The best way to overcome these potential challenges and impacts is to simply make sure you are prepared as far in advance as possible. Approach the agencies early, giving yourself extra time to avoid delays in your overall development timeline.
Each type of submission and meeting with FDA has specific requirements as described in 21 CFR and in associated guidance documents. Make sure that you understand precisely what is expected of you by FDA and/or the EMA/local national agencies.
FDA reviewers are scientists who make decisions based on your arguments backed up by relevant data. All of your interactions with the regulators should be based upon a transparent scientific approach, so now is the time to be preparing for that and making sure any and all data and information necessary will be available for the meetings, submissions, etc. that you have planned for 2021.
FDA continues to insist on higher levels of quality. Submissions should be proofread for the following:
As you think about the submissions that you are planning to file with regulators next year and the timelines and related activities to be completed, it is critical to factor in ample time for review and proofing of the content before it is sent off to the applicable Agency.
The differences between great and mediocre meetings are measured in years of time and millions of dollars. When preparing for formal meetings with regulators, here are a few things to keep in mind:
Preparing for the upcoming year may seem like a daunting task, however, with the right approach in place it can become quite manageable. If you need assistance developing your 2021 approach, ProPharma Group’s experts can make sure you are prepared. Contact us today to learn more about our global suite of regulatory affairs services.
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