scientific advice

Scientific Advice – Protocol Assistance.

Saving sponsors time and money.

What is Scientific Advice?

Scientific Advice is a formal way for sponsors to get regulatory agency feedback on their proposed development plans before committing time and expense. It can be particularly useful for products being developed for rare diseases, first-in-class products, or when there is a need or desire to deviate from existing published guidance. Sponsors can seek feedback on CMC, Non-clinical and Clinical issues.

What is Protocol Assistance?

Protocol Assistance is the term the EMA use to describe Scientific Advice for a product with an EU Orphan Designation. Contrary to the name, advice can be sought on the full range of development questions and is not just limited to protocol design and can be sought from EU (and UK) national competent authorities. These meetings tend to be in person (or video due to Covid) and result in written advice being issued after the meeting.

What is the EMA procedure?

The standard procedure for EMA Scientific Advice or Protocol Assistance is to provide written advice, however, if the EMA feel a discussion is needed after a review of the questions, they may request a meeting to cover these aspects specifically. After the meeting they will provide their full written advice on all questions.

The expectation of such meetings is that sponsors will submit a list of questions that they would like to seek agency feedback on.  It is important to remember that for each question, the sponsor is expected to state a reasonably detailed company position to their own question and provide a full justification for their reasoning, including any references or data to support.

In addition to standard Scientific Advice/Protocol Assistance, the EMA also offer Parallel scientific advice with the FDA and parallel consultations with EMA and EU Health Technology Assessment bodies.

How can we support you with Scientific Advice or Protocol Assistance?

Arriello supports sponsors with the navigation, preparation for, and attendance of scientific advice and protocol assistance meetings and other agency interactions. Our support usually begins by developing a strategy that covers the following considerations:

  • When to obtain advice.
  • When NOT to obtain advice.
  • Which agency or agencies to approach?
  • For products that will ultimately be authorised via EMA Centralized Procedure, should you approach the EMA first or obtain national advice before that?

Once the decision to approach the EMA has been taken, Arriello can further support sponsors as with all the connected requirements needed.

Coordination & Agency Liaison.

An assigned Arriello Regulatory Consultant will coordinate and liaise with all appropriate agencies to set up all advice meetings, provide any required materials, and ensure the procedure is as seamless and easy as possible.  They are your main point of contact and will also coordinate with our subject matter experts to ensure the efficient provision of all deliverables.

Questions & Company Positions.

Our Regulatory and Subject Matter Experts can review your existing data together with any proposed development plans and advise on the questions that should be considered. 

Some clients already have some questions in mind or have questions that they have already asked the FDA or other agencies. In that case we will review and adapt as appropriate to make these relevant for the EU and suggest any additional questions that may be relevant for the EU also.

Briefing Book.

A Briefing Book will be needed to accompany any company questions. This provides the EMA or other agencies with an overview of the product and includes any relevant background information that is pertinent to the questions being asked. 

Arriello can assist sponsors with drafting, review and finalizing a quality checked and fully formatted briefing document. We are also very familiar with adapting and repurposing existing FDA briefing books. 

Attendance at Meetings.

Our Regulatory, and if applicable Subject Matter Experts, can support sponsors by attending Scientific Advice meetings. We can guide you by having rehearsal meetings and calls and giving an overview of the process to your team. 

Our Regulatory Lead will take the company minutes at the meeting and share these after for client input and review before finalizing and sending to the agency.

Agency Fees for Scientific Advice.

The fees charged by various agencies vary dramatically and according to the type of advice requested. For Sponsors that meet SME criteria significant discounts on agency fees may be available. 

Arriello can support qualifying companies to obtain an SME designation.

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