Briefing books were prepared by the developer and supplied eight weeks prior to the meeting and only verbal advice. Briefing book or briefing materials voisin consulting. The briefing book provides us with all the important information about your project. The regulatory agencys responsibility is to provide advice to sponsors by answering questions related to development of medicinal products that sponsors have specified in an appropriate application form and sent to the regulatory agency. Nice and the role of scientific advice in shaping access strategy. Scientific advice may be provided at any time before or after the initial authorisation of the medicinal product. Health canada invites sponsors to request a precta consultation meeting. Participating in scientific advice generates alignment and marks a willingness to communicate with regulators and hta bodies, meaning that evidence plans are less likely. Standard scientific advice scientific advice life sciences what. We offer endtoend development solutions for your product or device, starting with early development advice, including regulatory advice meeting planning, development of market access strategies, marketing applications and post marketing activities all from one source. Best practice guidance for the parallel regulatory hta scientific advice procedure. Regarding the timeline of the procedure, the circular considers a maximum of three months 90 days after validation of the complete set of documents. Scientific advice and protocol assistance european medicines. For the required fee, cadth provides highquality, thoughtfully considered scientific advice that is informed, specific, timely, and fit for purpose.
A briefing document is a good communication vehicle to keep others abreast of certain issues in a professional manner. Mhra scientific advice briefing document proposed vaccine. Book scientific advice meeting wriben record of scien. Best practice guidance for the parallel regulatory hta. Once the briefing book has been submitted, the next step is a facetoface meeting at the ema to discuss the briefing book, after which nice will.
Briefing book or briefing materials documentation submitted to facilitate an agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. The development of clear value propositions, underpinned by the evidence in order to help communicate the unique value of your product or intervention. Health authority briefing documents also known as briefing packs, briefing packages, and briefing books are documents prepared by a pharmaceutical company to support its interactions e. Production of early scientific advice briefing books dossiers in oncology for hta in 3 eu countries. Guidance on the briefing book for cadth scientific advice 2 november 22, 2016 2. Through our experience with the scientific advice team, weve compiled crucial information for our members such as. Replace information in brackets with relevant information on your productcompany. Draft agenda with the issues to be discussed proposal for the style of the meeting.
Early scientific advice obtained simultaneously from. The company seeking advice has to contact the unit up to 9 months before the actual meeting and prepare a predefined briefing book with all relevant. Advice was sought for two development compounds in different disease areas. But, in a global pharmaceutical business, many clients are looking to develop drugs for both the us and eu markets. The briefing book follows a standard format and should include the. Keep the book simple and clearly headline each section so that its easy to find things. The briefing book is the reference document containing all the information and questions used within the joint psa process seeking early scientific advice from eu payers 12.
Looking for some tips for writing a briefing document. Whether you prefer pay as you go ad hoc advice, or a full fixed fee project management service, we can help. Although scientific advice is not a requirement for approval, it is important to note that maa approval rates are much high for companies who seek the agencys advice and follow it. Prepare briefing documents and submission of briefing book package. Absurd scientific advice for common realworld problems is the new book from xkcd cartoonist randall munroe. Briefing book that consists of background material about the product along with the questions that the manufacturer. The process parallel consultations pc start with the submission of a letter of intent followed by a briefing book sent to ema and eunethtas early dialogue secretariat. At day 0, the ed request is submitted to the medicines assessment department of has via a letter of intent.
Roadmap for clinical development success michael rozycki, ph. Applicant agrees to notify icmi of the occurrence of a significant cyanide incident at any of its operations listed in part ii of this application. Briefing book guidance for company general points for preparing a briefing book. Advisory committees about fda public advisory committees, calendar of meetings, meeting materials, how to become an advisory committee member, guidance, and faqs. The focus was on matters of common interest to the tga and the pbac i. Preind and scientific advice meetings by the time a typical virtual biotech company is close to first in human studies there is often a web of data generated over years often at many cros. Nice and the role of scientific advice in shaping access. The briefing package contains background information prepared by the food and drug administration fda for the panel members of the advisory committee. It starts with a briefing book, including key questions, being submitted to nice scientific advice, and finishes with the final report. Briefing book for ema qualification procedure actibelt and therefore recommend that the sponsor pursue a formal scientific advice or qualification procedure. Depending on whether you wish to seek advice on a pharmaceutical or a medical technology, we have different requirements for the. Chmp scientific advice briefing document template standard headings in the template should be used whenever possible.
Tasks like scientific advice meeting and briefing book will be your daily bread and butter, so that you will costantly learn something new. It should include details such as the products background, evidence to date and. Tips for writing a briefing document yourdictionary. Hdguidance document scientific advice maghp qmident. In order to have continuous successful development, we are following the recommendation of the itf from 17 november 2016 to request an ema qualification procedure with the goal of. Flutcore universal influenza vaccine active substance. Prevention of disease caused by influenza a virus the intention is to expand the vaccine and the indication to. Scientific advice briefing book, study design, cmc, preclinical. Ema provides scientific advice to support the timely and sound development of. Each session lasted for approximately two hours and was structured around the questions in the briefing books.
It should contain company questions, justifications or company positions, and appropriate summary information. For the ema, the scientific advice or protocol assistance is provided pursuant to article 57 1. Put yourself into the shoes of regulators while preparing the briefing book as. Pdco, comp option for a presubmission meeting hta bodies parallel regulatoryhta advice. We understand that your journey from discovery to approval can be challenging. A potential to vet your briefing book generate interest in becoming rapporteur ema scientific advice working party sawp potential input from other scientific committees, e. Camargo is known for its expertise in the 505b2 pathway. Use the provided template to submit a briefing book bb to nice scientific advice sa in microsoft word format.
It should be highlighted in the subject heading that the submission concerns a request for scientific or procedural advice. Early crossfunctional alignment on requirements can avoid lastminute shifts in evidence planning that can be very costly. The italian medicines agency experience with hta scientific advice. It should include details such as the products background, evidence to date and any proposed trials. Main features of scientific advice procedures in the eu and us. Request for scientific advice by the innovation office. For human medicines, scientific advice and protocol assistance are given by the. Complete a letter of intent using the and prepare a briefing document giving an introduction to the medicine under development. The use of health technology assessment hta to inform policymaking is established in most developed countries.
Briefing book that consists of background material about the product along with the. Use the provided template to submit a briefing book bb to nice. Both nice and the ema will assess the briefing book separately and the company will receive two separate list of issues from each stakeholder, respectively. The role of health technology assessment bodies in shaping. Such consultations may be particularly useful for new active substances or applications that will include complex issues that may be new to health canada. D vice president and head global regulatory affairs asia. Use the provided template to submit a briefing book to cadth scientific advice in microsoft. This letter word document includes the brand name and the international common denomination of the drug, the claimed indication be precised, for example state the line of treatment and how the drug fulfils the 3. Guidance on the briefing book for cadth scientific advice. Chmp protocol assistance scientific advice briefing document template. This takes four forms standard scientific advice, light scientific advice for small to medium enterprises smes, htaema scientific advice and nicemhra scientific advice. It is very important that the briefing document identify the issue in the most concise manner possible and propose a solution. This is why we believe that even at proof of concept stage, expert advice can mitigate project risks.
New process for early scientific advice from the ema and hta bodies. Briefing dokumente mussen dem pei 3 wochen vor beratungstermin vorliegen. You will very rarely get bored at this position, even long time after your day one in this firm. The aifahtasa procedure relates the assessment of manufacturers briefing book. Workshop on hta evidence generation requirements for developers of cell and gene therapies. Senior regulatory affairs scientific advice meeting. Briefing book for ema qualification procedure actibelt and therefore recommend that the sponsor pursue a formal scientific advice or.
Workshop on hta evidence generation requirements for developers of cell and gene therapies clare beach 1st august 2016 nice scientific advice. Requesting scientific advice or protocol assistance from. Early scientific advice international perspectives don husereau bscpharm, msc don. Preclinical trial application cta consultation meeting. In the context of preparedness for the uks withdrawal from the european union eu, ema advises ukbased micro, small and mediumsized enterprises smes to note the deadlines published on the brexitrelated guidance for companies webpage regarding the date of uks withdrawal from the eu when applying for scientific advice and protocol assistance in order to continue be eligible for financial. In order to be in a position to offer a slot for the organisation of a scientific advice meeting, the scientific advice unit needs to receive first both a request letter and a briefing book.
The concurrent scientific advice process works alongside ema timelines and requires submission of the same briefing book provided to the ema. In this podcast extra, randall talks about the book, its. Enclosure to the cover letter is the application form. The scientific advice is based on background information and questions or issues identified in a briefing book prepared by the applicant. These processes start with an initial discussion on the proposal, followed by the submission of a briefing book. Involved in all the steps of scientific advice briefing book preparation, package submission, meeting planning prepared clinical trial applications for 1 interventional and 1 non. Requesting scientific advice or protocol assistance from ema. Scientific and regulatory advice by the federal institute for drugs and medical devices. Following is a template to help guide you as you put together your own briefing book. This document, which should be no longer than 50 pages.