In the case of diseases that has a global pandemic like COVID-19, I have seen simplified regulations to produce products rapidly.
In this case, I am wondering what kind of change there is in the initiating and planning phase of project management.
Also, if the pandemic is over, will these companies have to go through the previous regular regulations?
The COVID-19 vaccinations received emergency use authorization which is the FDA's way of expediting its availability during a public health emergency, when no alternatives exist, and when the benefits outweigh the potential risks based on interim or final phase 3 clinical trial data. Nevertheless, the FDA had to ensure safety and efficacy first before granting authorization. The FDA continues to regulate products even after they receive approval. In the case of products which receive emergency use authorization, that authorization can be changed or revoked but only lasts for as long as the public health emergency. The companies then pursue full FDA approval - as was the case with the Pfizer and Moderna vaccine as well as the use of Remdesivir.
In the case of the initiating and planning stages I am sure the changes are not drastic other than the timeline being much tighter than it would be normally for products that are meant to aid in the pandemic. As mmodi mentioned above emergency approval had to be granted to the vaccines to push them through as fast as they did. However, I do not think this will be a thing that continues after the pandemic as there is already a framework in place for going back to the old system after the pandemic. The only thing that might happen is people claiming these products that received emergency approval as substantially similar to a product that they are trying to get approved however as mmodi had said many many of these products are pursuing full FDA approval once the emergency approval runs out so ther should be no risk of this.
Being working in the pharmaceutical sector and working on the development of the COVID Vaccine, I could tell that the initiating and planning phase that we experienced was not all that different from what would be done otherwise. All practices or qualifying an assay and rigorous testing and methods of data collection were all in place and those key development of the scientific theory was not ignored or cut corners. All that was changed in the field was the timeline and the financial liberty we were allowed. Oftentimes, in pharmaceuticals, the biggest time consumption is the human factor in that people have days off and have other prior commitments. During the pandemic, we saw points where individuals had to come in on weekends and work regular shifts, albeit being paid accordingly. And other means necessary to meet the tighter deadline. However now, when we have other projects, the original timelines that usually are set are back in place and the rigorous testing and regulations are back in action.
The COVID-19 pandemic had large repercussions to the initiating and planning phases of many medical device projects. The supply chain issues that continue to reverberate through the industry due to the pandemic have thrown a wrench in the planning/initiating phases of just about every engineering project since. Many considerations have to be made during these phases – such as including extra time in the ghannt chart to account for potential delays or shortages in equipment or supplies. Additionally, if possible, it is important to have multiple suppliers validated for each component in order to have back up options in case there are supplier or supply chain issues. I think the COVID-19 pandemic also changed the way people work on projects. Although most companies have moved back to in person work, it is important to account for people working remotely and collaborating using virtual or digital tools when managing projects.