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As an applicant for a centralised marketing authorisation, you may need some advice and assistance, so your new veterinary medicinal products gets to the market as soon as possible and with a clear and satisfying Summary of Product Characteristics (SPC).
I have a lot of experience with the decision making procedures in CVMP/EMA, and with the rules and best conduct for applicants, who apply through the central procedure.
This knowledge is valuable for you when planning your submission, when you have strategic decisions to make about your product and when the procedure progresses with exchange of documents, meetings and contact with the Rapporteurs, the EMA Project Manager and the CVMP.
The scientific content of the documentation is crucial for your success.
Well-conducted studies and clinical trials can withstand the critical evaluation of the assessors. The way studies are reported and presented together with the overall purpose of the product and the scientific literature behind, is also extremely important for a positive benefit-risk response from the Committee.
I can provide you with my experience as assessor, Rapporteur, CVMP-member and -chair from 18 years in the field, when you need to decide on the contents of your dossier and ensure that you understand your options and choices.
Please do not hesitate to contact me for further information on how I can assist with your application.
When you have submitted the application dossier to the authorities or EMA, the evaluation phase starts. This always results in a List of Questions to the Applicant, which you must answer satisfactorily to get the approval.
However, it can sometimes be difficult to understand exactly what is requested by the assessor, or in particular what your options are, if you cannot directly satisfy the requirements, or if there are data gaps in your dossier or flaws in a particular study.
The language used in asking the questions, will often indicate how “hard” the request is meant, and the guidelines – or precedence cases – may give you options to tailor your response, so it will still be accepted by the assessor.
My unique and special insight in how Lists-of-Questions are produced and negotiated in the procedures may give you the necessary understanding of your situation, and eventually the strategic options you are looking for.
Please do not hesitate to contact me for further information on how I can advise or assist you with the answers to your List of Questions.
When an authority considers that there is a major problem with a product, or a group of products, a referral can be made under Dir 2001/82 (as amended) article 33, 34, 35, 39, 40 and 78.
Then the CVMP will be asked to evaluate the products and the topic in question and give an opinion, which the EU Commission will base its binding decision on.
Your product may be included in a referral based on an application that you have submitted in a national, MRP or DCP procedure, or it may be drawn in because of problems with a similar product in the EU (class referrals).
In any case, you have the opportunity to respond to the questions posed by CVMP and to defend your product and its authorisation conditions. The better you respond, the bigger is your chance of a good result.
Some referrals end up with an Oral Explanation, which can be the crucial tipping point for the outcome for your product.
My long experience with referral procedures can help you get the best possible result.
If you need further guidance on the referral procedures or on your specific situation, please do not hesitate to contact me.
When your application procedure is approaching the end, i.e. after you have responded to the List of Questions, there may still be topics that are not accepted by the assessors.
You will then receive a List of Outstanding Issues (LoOI) with a very short response time. Sometimes this LoOIs is divided into major and minor questions, and although the major questions are the most important and relate to your chance of approval or e.g. to the proposed indication, all outstanding issues must be answered satisfactorily.
Often you will also be invited to present your answers to one or two crucial topics in an Oral Explanation in front of the CVMP.
These topics (or gaps) are typically so severe that a non-satisfactory response will render the application not-approvable. It is therefore of utmost importance that your company delivers a professional and well-considered presentation and performance in the OE and that you can answer the questions from the committee members during the plenary discussion.
With my long and unique experience in exactly these procedures, I can advise and assist you with a critical review of your slides, detailed discussions on possible questions and training of the speakers before the event.
Depending on the topic, there may be more options to consider, even if you cannot satisfy the requirements at the present time point. You would want to have these potential options with you, in case the committee does not buy into your view on the application, so you have explored all possibilities for a positive opinion.
Please do not hesitate to contact me for further information and assistance. e-mail: firstname.lastname@example.org
Scientific advice can be sought through the CVMP’ Scientific Advice Working Party - veterinary (SAWP-v) and EMA to give more predictability of the regulatory acceptance of a scientific approach, such as a specific design of a clinical study, and is given particularly in areas where no guidance existsor the product does not fit exactly within the scope of existing guidance.
Most companies or teams only go through a very limited number of Scientific advice procedures and lots of effort goes into preparing the request. The option to have a joint scientific advice with FDA and EMA gives possibilities for global product development.
While the details and scientific content of any such advice should be left to the real experts, the way you ask the questions and the information you provide to the assessors is fundamental to the quality of the scientific advice and its usefulness for you in the subsequent work.
I have participated in the work of SAWP-v for 12 years and followed many discussions on how to give an adequate response to unclear questions from an applicant.
Please do not hesitate to contact me for further information on how I can help you with the formulation and presentation of the questions, in order to get good and clear advice from CVMP. e-mail: email@example.com
My background from pharmacovigilance in the Danish Medicines Agency gives me a broad overview on the structures and contents of veterinary pharmacovigilance in EU.
The participation in strategic development of the government-side of PhV has been one of my favourite tasks, and always with the intention of making a useful and simple system for the benefit of veterinarians who handle the medicines out in the real world.
If you have concerns or specific requests in pharmacovigilance or Periodic Safety Update Reports (PSURs), I can assist with the understanding and handling of many topics in this field. email: firstname.lastname@example.org
The legislation requires that the application dossier contains a review by an expert, the Detailed and Critical Summaries (DACS), for each part of the application dossier.
I can assist you with my many years of experience as an assessor and Rapporteur and review or produce expert reports for the safety and efficacy parts of your dossier for pharmaceutical or immunological veterinary medicinal products, including GMOs. e-mail: email@example.com
Quote from Directive 2009/9 on Immunologicals, DACS:
C. DETAILED AND CRITICAL SUMMARIES
Each detailed and critical summary referred to in the second subparagraph of Article 12(3) shall be prepared in the light of the state of scientific knowledge at the time of submission of the application. It shall contain an evaluation of the various tests and trials, which constitute the marketing authorisation dossier and shall address all points relevant to the assessment of the quality, safety and efficacy of the immunological veterinary medicinal product. It shall give the detailed results of the tests and trials submitted and precise bibliographic references.
All important data shall be summarised in an appendix to the detailed and critical summaries, whenever possible in tabular or graphic form. The detailed and critical summaries shall contain precise cross references to the information contained in the main documentation...
Many things can affect your product’s way to an authorisation.
For many global companies it is essential that the studies have a scientific approach that leads to global acceptance of the design and results. My experience from VICH can help you get the study design right, so you avoid having to repeat studies to accomodate for the rules in different countries or regions.
If your product is intended for Minor Use or Minor Species (MUMS), reduced data requirements may be applicable, and there may be easier access to a scientific advice. I can assist you in the process of asking for MUMS status and clarifying the rules.
If your product is for a food-producing species, you need to clarify the status of Maximum Residue Limits (MRL), and whether your product contains active ingredients or excipients that do not have an established MRL (i.e., not yet included as an 'allowed substance' in table 1 of the annex to Commission Regulation (EU) No 37/2010).
You may also ask for a substance to be added to the Out of Scope-list, where you don’t have to have an MRL entry.
If you need a professional report of your conference or workshop, I can help you out. And if you need help and preparation for a public meeting, hearing or other topics within veterinary medicines, please give me a call.
My experience in these and other regulatory questions related to the content of a dossier can assist you in making the right strategic choices for your product. e-mail: firstname.lastname@example.org
Training Courses on registration of veterinary medicines in Europe, Referrals, Minor-Use-Minor-Species, Centralised procedures, etc are available in collaboration with Cyton Biosciences. Click on the pictures below for dates and information.
Specialised courses related to your product portfolio can also be arranged.
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