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A kick-off meeting (KoM) with regulatory agencies marks the beginning of a collaborative journey towards pharmaceutical product approval and compliance in the pharmaceutical industry. This is a crucial meeting that brings together key stakeholders from regulatory affairs services agencies and pharmaceutical companies in order to establish clear objectives, expectations, and timelines for the regulatory submission process.

What happens in a Kick-Off Meeting?

During the KoM, both parties discuss the regulatory requirements, submission guidelines, and necessary documentation for approval. This includes understanding the specific regulations and standards that are relevant to the drug or medical device services being developed. The meeting often covers topics like data requirements, clinical trial protocols, safety and efficacy data, manufacturing processes, labelling, and post-marketing surveillance plans.

The KoM is a platform that facilitates open communication where questions can be asked, clarifications may be sought, and potential challenges addressed. It is an opportunity to align regulatory strategies, set milestones, and allocate resources effectively. Building rapport between regulatory agencies and pharmaceutical companies are important aspects of the KoM. The goal of a KoM is to ensure a smooth and successful regulatory submission process that leads to the timely approval and market access for pharmaceutical and allied products.

Is a Kick-Off meeting different to a Scientific Advice meeting?

Yes. A KoM is usually shorter than a Scientific Advice meeting and is for general issues such as formal prerequisites regarding a particular application process, or determining the eligibility to apply for a pathway/process. On the other hand, a Scientific Advice meeting addresses more specific concerns like detailed and product-related prerequisites for a particular approval application, including specific documents or methodologies to be submitted.

Typically, in order to request a KoM, applicants should generally submit an meeting request application form and put together a briefing document regarding the particular project, product summary, topics, background information, and questions. The agency usually checks the documents and organizes the team of advisory members for the KoM. The appointment is coordinated between both stakeholders w.r.t date and time of the meeting.

Conclusion

KoMs are important in ensuring the smooth regulatory approval process of pharmaceutical and allied products. These meetings help in supporting open communication, alignment of strategies, and help provide clarity regarding regulatory requirements and expectations. KoMs bring together key stakeholders from the agency and pharmaceutical company’s side to help identify potential challenges early on and develop solutions in a collaborative manner.

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