Get Your Pharmacy Receipt Sample for Research and Development Effortlessly

Pharmacy receipt sample for Research and Development

[Music] [Music] [Applause] dear all um welcome to today's session of our coffee break webinar on Clinic Tri in the pharmaceutical area tips and tricks for CTA negotiations a quick introduction ahead my name is enen I'm a lawyer in Taylor westing's Life Sciences team in Munich and I am advising pharmaceutical and medical device companies on regulatory aspects in the Life Sciences sector and all industry specific agreements um a focus of my daily practice is advising on clinical trials and clinical trial agreements so it's my pleasure to give you a quick overview um of the most important aspect with regard to clinical trials and clinical trial agreements today so let's uh switch to the agenda um I will start by giving you an overview of the regulatory landscape for clinical trials with medicinal products and in particular the clinical trials regulation the CTR um we will then have a look at the main Novelties introduced by this CTR and then take a look at the new approval procedure for clinical trials in the European Union after this regulatory overview we will um look at the most important points in the context of CTA negotiations we will start uh with the use of CTA templates move forward to the Contracting parties of a CTA discussed the impact of the general data protection reg regulation the gdpr on the relationship between sponsor and trial sites um the hospitals on the one hand and the impact of the gdpr on the drafting of the informed consent forms the so-called icfs on the other hand and then we will turn our attention to really high negotiated provision and ctas the remuneration of so-called employee or service inventions by the sponsor which is um crucial when a German trial site conducts a clinical trial on be behalf of a sponsor so let's start with the CTR the clinical trials regulation in January 2022 this new regulation on clinical trials on medicinal products enter Ed into full force this regulation replaces um the former gcp directive the good clinical practice directive and um through its unrestricted applicability in all member states of the European Union the CTR leads now to a um harmonization of the application procedure the approval and the supervision of clinical trials in the European Union by competent authorities um just to give you a quick background information ing to the European commission when drafting the CTR um the experience with the former gcp directive had shown that the harmonized approach to regulating clinical trials in the European Union had only been partially achieved by the gcp directive there have been different application requirements established by the gcp director for the approval of Cl iCal trials in all member states which led uh from the perspective of pharmaceutical companies or sponsors to increase um costs and delays in the start of specifically multinational clinical trials so clinical trials which uh are to be conducted in more than one European Union member states and from the perspective of competent authorities in the member states the gcp directive had led to an inefficient uh use of resources due to unnecessary multiple assessment of the same information so it's uh the approach of the European commission and the CTR to facilitate the conduct and the approval of clinical trials and the European union now um with regard to uh the applicability of the CTR the CTR provides for a transition period of 3 years for cl iCal trials as of January 2023 uh 2023 so last year all applications for new clinical trials in the European Union had to be submitted through a new database the clinical trial information system which I will explain to you in a few minutes um and in ance with the new CTR requirements and another important timeline as of uh January 2025 and thus next year after the expiry of the transition period of three years all clinical trials that have been initiated under the former legal framework of the gcp directive will have to be transferred to the new CTR and the new clinical trial information system so you have to submit all study documents uh and enter them into the ctis in case you are affected um for the transition of clinical trial initiated under this former gcp directive under the CT uh into ctis um the EMA has published a questions and answers documents entitled ctis how to get started and how to transition to a clinical uh how to transition a clinical trial so take a look uh at this question and aners documents in case um um you have a clinical trial ongoing and initiated under the gcp directive what are the main changes under the CTR to fulfill the approach to facilitate clinical trials in the European Union so first of all we have a new approval procedure for clinical trials which we will assess on the next slide uh in a few minutes um we have a new database for clinical trials the clinical trial information system the CT from now on sponsors have to submit their application uh documents for the approval of intended clinical trials through this one Central online platform which um acts as a communication platform between the sponsor and the member States involved in the approval procedure the submission of applications through ctis is and this is interesting mandatory for both monal and Multinational clinical trials uh moreover we have new definition definitions um with an extensive catalog of uh only partly new terms um the CTR now contributes to a uniform understanding of the terms um used in the context of clinical trials the CTR moreover introduces a new regulatory responsibility it provides um the possibility of clinical trials to be conducted by more than only one sponsor which has the has been the case um under the gcp direct so a clinical trial can now be conducted by several sponsors um this is the so-called concept of co-sponsoring um the primary requirement is above all a clear allocation of tasks and division of all sponsors responsibilities in a written agreement to be um concl uded between all co-sponsors and this new provision is um intended to simplify the procedure for all um informal networks of researchers or research institutions uh through shared responsibilities and the opportunity of um but the opportunity of co-sponsoring is not limited to only investigator initiated tries and the like but can also mean more flexibility in corporation for smaller pharmaceutical companies to uh act as co-sponsors as well as research corporations between the pharmaceutical industry and academic institutions on the other hand so they all can benefit from this new Option of co-sponsoring moreover we have um substantive legal requirements for the um protection of child subjects um the provisions on the prot setion of trial subjects are now extensive extensively framed with um detailed requirements for the informed consent we have General protective um Provisions applicable to all trial sites uh trial subjects um the CTR provides detailed uh requirements for the inclusion of um miners adults who are not able or not capable of giving consent um patients in emergency situations and Pregnant and breastfeeding women and last but not least um the CTR has extended the retention periods in addition to concrete requirements for the storage of The Trial Master file of the clinical trial um the CTR now obliges investigators and sponsors uh to store the content of their trial Master file for a period of uh 25 years after the end of the clinical trial so this is a novelty that should from now on be uh specified ingly in your clinical trial agreements now let's have a closer look at the approval procedure under the CTR um the approval procedure is divided into three parts as you can see on the slide the validation procedure on the left side the um assessment of the application documents by all competent authorities of the member states um where the intended clinical trial shall be conducted in the middle section and the final decision decision um which will be submitted by the competent authorities to the sponsor through the clinical trial information system at the end in case of multinational clinical trials one member state which will be appointed by the sponsor itself um will take over the coordination of the approval procedure as the so-called reporting memb State RMS as you can see on uh the left side of uh the slide the validation process usually takes 10 days and it only serves to check the completeness completeness of all submitted application documents um the advantage of the CTR is is that the application documents only have to be submitted once for all member states so you don't have to submit your application documents to each competent authority of all member states and each competent ethics Committees of the respective member states so it's only one application through ctis and it will then be disclosed to all the member states and their competent authorities and competent ethics committees so this is the big advantage AG of the CTR and this new approval procedure and in addition the application documents are now set out in Annex one to the CTR it's an really extensive list but now the sponsors do not have to comply with different requirements in each member state where they wish to conduct that clinical trial so we have a uniform application dosier to be submitted through ctis um the validation of the application documents is um Then followed by the actual review of the application the so-called assessment procedure as um stated in the middle section which is divided in two different parts both parts are conducted in parallel and for a period of 45 days part one of the assessment or part one is the assessment of let's say General and scientific aspects of the the clinical trial to be reviewed by the reporting member state in its own responsibility so choose your reporting State wisely with regard to these general or scientific aspects of the clinical trial this member State um will also have the responsibility of reviewing the trial in a manner that is um in a manner that is binding for all participating member states in which the clinical trial is also to be to be conducted Ed a deviation of the member states from the assessment of the reporting member state to this part one um is only permitted in strict exceptional cases so this is one more mechanism to uh speed up the approval procedure now part two of the assessment concerns um the ethical and National aspects of the clinical trial and um this part two assessment will be conducted by each member State concerned in their own responsibility and for their own territory and just to give you an an impression of the scope um the scope of this part two review by the member states concerned mainly um comprises National aspects such as the safety of the child subjects uh the review of the ICF for example the qualification of the clinical trial team and the suitability of the trial sites um the approval procedure let's let's just uh skip the extension periods in um uh in the middle section the approval procedure ends with one binding decision as to whether the clinical trial may be conducted may not be conducted or may only be conducted subject to um specific conditions and the sponsor will receive one decision uh one approval through CTI now let's move forward to the ctas and the CTA negotiations um most of our our clients use their own CTA templates to start the CTA negotiations with the trial sites but um depending on the countries where the clinical trial should be conducted you should be of you should be aware of the fact that there might be binding or semi binding CTA templates published by competent authorities or competent ethics committees which is the case for example in France or semi binding in Italy Hungary and Greece so please don't be surprised when a trial site rejects your CTA template and refers to the binding CTA templates in this specific country with regard to those binding or um semi binding CTA templates um the scope of permitted changes depends on the respective member states and um concerns highly likely um commercial aspects between the sponsor and the trial site such as the budget and payment Provisions so please align with your lawyer on uh the changes you wish to implement in such a binding CTA template prior to submitting prior to submitting such CTA for approval to the competent authorities in order to avoid rejections and delays in your clinical trial one more novelty for today at the beginning of this month uh the so-called German medical research Act was passed in Germany which also has an impact on the conduct of clinical drug trials in Germany um on the one hand the Rivia periods for um solely mono National clinical trials to be conducted in Germany are now shortened there are a few other Novelties um um which uh you can um get um familiar by um yeah just um checking uh this um German medical research act um on the other hand um apart from uh the legal Novelties um the Federal Ministry of Health has announced um the publication of sample contract Clauses for clinical trial agreements which is new in Germany um these um sample Clauses are not yet available however you should keep an eye on on the current developments in check uh when uh these contract losses are published by the Federal Federal Ministry of Health um these contract Clauses will have an impact on your contract negotiations also not binding um it is to be expected that um German trial sites uh might insist on the use of these sample contract Clauses or at least on the use of certain provision in order to significant significantly speak speed up contract negotiations but um these Clauses can of course um provide a basis for all sponsors to draw up their own CTA templates if they do not yet have their own t templates uh drafted however we always recommend um that you uh critically review the uh individual provisions and adap adapt them to your specific needs for example to amend um the provisions on the protection of your confidential information or the transfer of Ip and not to implement and use them without any um further review another initial question is who shall be the Contracting parties to the CTA besides the sponsor of course only the trial site or the investigator or both the answer is always depends on the member state where the clinical trial is to be conducted in Germany for example trial sites usually object to enter into three party agreements um with the investigator being a Contracting party besides the trial s side and the trial sites usually insist on entering into the CTA with a sponsor without the investigator being a contract Contracting party the reason for this is simple um German trial sites want to avoid that the invest Gator um becomes liable under the CTA for any misconduct and uh is then subject to claims made by the sponsor towards the investigator but in Poland for example um polish law deems it necessary that um the investigative investigator becomes a Contracting party to the CTA so it's up to you the trial sites and the investigator to NE negotiate either a CTA between the sponsor and the investigator and the sponsor and the trial site or uh negotiate a three-party agreement with the trial site and the investigator as the Contracting parties if the investigator does not become a Contracting party to the CTA um it is common practice and recommendable to let the investigators sign a read and acknowledge section on the signature page of this CTA where the investigator states that he or she has not only read the provisions um of the CTA um but also acknowledges all the obligations addressed uh or assigned to the investigator under the CTA and the clinical trial regulation as well as all other applicable laws of course uh moreover um please make sure um that you have a provision in the CTA in place that states that it is a general obligation of the trial site to ensure that the investigator fulfills its obligation assigned to him or to her in the CTA or by applicable laws such as um the CTR now let's move forward to another important regulation uh the general data protection regulation I'm sure that you've uh aware of the GTP uh and um already came along um um uh of the provisions of the G gdpr the CTR clearly states that the provisions on data protection stated in the gdpr need to be observed in addition to the provisions of the CTR with regard to clinical trials so both regulations are applicable in parallel the gdpr requires a legal basis for the process of personal data so when conducting a clinical trial you are obtaining and processing personal data of study subjects and for this process of personal data even if it's poniz data in case report forms for example this poniz data is regarded personal data under the gdpr so that the requirements of the gdpr have to be observed with regard to this these um poniz data and in order to process this personal um sodomized data uh you need um a specific legal basis um in Germany we don't have a specific legal provision in the German medicinal um products act or in any privacy uh specific privacy laws so the legal basis for the process of personal data is the inform consent of the clinical trial subjects um but it's um up to the European member states to further develop such a legal basis so just um remember in Germany we always need the informed consent of the trial subjects in order to be allowed to process their personal including poniz data and um and the way to obtain their uh informed consent is um informing them not only about the risks and benefits of the clinical trial but also about the scope and the type of data you as the sponsor will process during and after the conduct of the clinical trial so uh if you've already read an ICF you uh may have noticed that the scope of the ICF is um um quite wide so we don't do not only have um the uh information given on the clinical trial itself but uh so many pages on the processing of the personal data and um in Germany for example it is quite common that the sponsor asks the child side to draft the ICF template which will then be used to obtain the informed consent of the um clinical trial subjects um but please be aware that uh the um drafting of the ICF which is to be submitted as part of the application documents in the approval procedures this is um the obligation the regulatory obligation of the sponsor itself so it's your obligation to ensure that all trial subjects have also been effectively informed in terms of data Protection Law and have given their consent to the processing of their personal data therefore or um it is essential that the ICF template provided by the trial site is checked by you as the sponsor to ensure that it also complies with the gdpr and all applicable local data protection laws um and just to give you an impression which data protection Provisions need to be uh stipulated in the ICF um don't uh don't worry we won't read this uh section 40b paragraph six of the German medicinals um medicinal products act but um this just to give you an impression of all the information uh only governing the data processing in clinical trials which needs to be stated in the ICF so when drafting the ICF itself or when reviewing the ICF you have uh received from The Trial s please make sure that all the requ requirements uh which I've listed you here um and which are stipulated in section 40b paragraph six of the ATN gazettes that all these requirements are covered in the ICF template just to avoid that uh you don't have um valid informed consent and uh you don't um you won't be uh you then won't be able to um work with the data you have obtained um one last but really crucial um Point uh or issue we are discussing with trial sites when negotiating clinical trial um agreements is the remuneration of uh so-called employee or um service inventions uh just to give you a little bit of background information to employee or service inventions in Germany um with regard to inventions in Germany um many special aspects of the German employee inventions act the must be OB observed which either you yourself must comply with because you are established in Germany or your Contracting partner the trial site must comply with if employees so their researchers are employed in Germany um the provisions of the German employee inventions act aimed to ensure that German employees receive um um reasonable contribution or reasonable participation in Inventions they made in the course of their employment if the employee exploits the invention in a commercial manner the German employee or researcher then has the right to an appropriate contribution to this exploitation of the service or employee invent itions and uh for service inventions made for employees at the German University this is the furest specific um section 42 of the um German employee inventions act also provides that in the event of the exploitation of the service invention by the German University um the the amount of remuneration shall be 30% of the income generated by the in University through the exploitation of the service invention um please note that um if the trial site transfers the rights to the service inventions uh to a service invention to a third party like you you as the sponsor of the clinical trial it's the obligation of the trial site itself to compensate its researchers this obligation to compensate the employee or always stays with the trial site as the employer which means above all that the trial site has to pay the employee a reasonable compensation for the transfer of rights to this employee inventions your company itself or you as the sponsor do not have to pay the employee inventors or researchers so this is a common un misunderstanding sometimes when negotiating clinical trials and employee inventions in Germany in general however it is usually the case that your German trial site will negotiate a specific provision in the CTA when it comes to the transfer of study inventions in general and now service inventions or employee inventions in particular um and this provision will aim to ensure that separate remuneration is paid to the trial site in the event of the transfer of the service invention from the University to you as the sponsor so if your Contracting partner the trial site is legally obliged by the U requirements of the German employee inventions act to remunerate its own employees they do not want to Bear these costs on their own as um they must contractually transfer the service inventions due to the requirements of the CTA to you and cannot use it themselves it is therefore important um to determine whether such a remuneration of the employee invention or service invention the sponsor needs to pay to the university or to the child side shall be already covered in um the CTA itself which we always Rec recommend agreeing on or uh if this remuneration should be reserved uh for a separate seate agreement to be concluded um by the sponsor and the trial site afterwards finally it um is interesting to note that uh section 42 of the German employee inventions act stipulates that employees of a German University have the right to decide whether or not to publish the results of their research the right not to publish research results is referred to as the so-called negative publication right in Germany negativ um the spe special characteristic of this negativ is uh that the university researcher cannot wave his negative publication right in advance towards his employer so towards the university the trial site but it is common for the researcher it is common practice in Germany at least for the researcher to wave this right uh his his or her negative right uh Visa v a third party like the sponsor you as the Contracting party of the University therefore it may be um necessary to obtain declarations from all University researchers involved in the conduct of the clinical trial otherwise there is the risk that the researcher will not report the results made in the course of the clinical trial through the university and the university will then not be able to disclose the results to you due to the lack of knowledge so we need a specific waiver um the waiver of the so-called negative right of publication um with regard to this right not to disclose employee inventions results made by the university researcher um we recommend attaching a specific template a specific waiver to the CTA which all researchers involved in the conduct of the clinical trial in Germany should sign in which they wave their right not to disclose the results and employee inventions Visa the sponsor not the university this is not enforceable but it is uh allowed to wave it towards you the sponsor the third party and moreover uh as uh stated on the right side please make sure that uh there is an obligation in the CTA that states that the university shall only involve employees in the conduct of the clinical trial who have previously signed such a VOR as provided for in the attachment to the CTA so the this is it many thanks for your attention for now um any questions um I didn't see any um questions uh for now but I'll wait a few minutes to give you the time to uh go through all the information provided in this short time frame we will send you um the video of today's uh webinar and the slides you've seen um right now after the webinar so you are of course welcome to write an email uh if you have any further general questions on the conduct of uh clinical trials with medicinal products in um the European Union and specifically in Germany so as there are no further questions many thanks again for your attentions attention and your patience today and yeah have a nice day