Karanovic & Partners的动态

Our Partner and Head of our Life Sciences Practice, Elvan Sevi Bozo?lu, PhD, represented our Firm, at the 10th Annual IBA World Life Sciences Conference, co-presented by the?IBA Intellectual Property and Entertainment Law Committee,?IBA Technology Law Committee?and the?IBA Healthcare and Life Sciences Law Committee, where industry speakers discuss hot topics and key developments covering the different sectors of the healthcare and life sciences industry. During her speech she emphasized the importance of balance between public health advocacy and commercial promotion and mentioned that even though countries share a common terminology approach, the interpretation of local regulatory bodies can vary significantly. #IBAMadrid?#WLCF?#LegalIndustry #pharmaceuticaladvertising?#compliance?#pharma?#lifesciences

In Canadian IP disputes, it is becoming increasingly popular for litigants to proceed by way of an "application" rather than an "action." Among their advantages, applications typically proceed to a hearing on the merits in a short period of time and require a shorter hearing, since there is no viva voce evidence. But applications are not without their disadvantages. Unlike in an action, there are no discovery rights or obligations in an application. Therefore, an applicant "cannot expect to be able to make his case out of the mouth of the respondent" (in the words of an oft-quoted Federal Court decision). Recently, in Bayer Inc. v. Amgen Canada Inc., 2024 FC 544 and EMD Serono v. Canada (Health), 2024 FC 562, the Federal Court confirmed that an applicant cannot compel an individual to attend an examination if that individual has not sworn an affidavit in response to the underlying application, and that the lack of such a procedure does not constitute a gap in the Federal Courts Rules. The moral of the story is that if a rightsholder's claim depends on obtaining information from a specific representative of an infringing party, then an action is preferable to an application. While a defendant to an action can select their representative on an examination for discovery, the Federal Courts Rules include mechanisms for compelling a specific individual to be examined (including 3rd parties). Such mechanisms are unavailable in an application and attempts to conduct discovery in the context of an application will likely be met with disapproval from the Court.

?? On November 12th, 2024 we invite you to the 3rd Conference on 'Law & Healthcare Policies', which will take place at the Wyndham Grand Athens Hotel, organised by NOMIKI BIBLIOTHIKI . ? ?? In Section III (12:00-13:20), on the topic Product Pricing – Competition – Supplies, distinguished speakers will discuss the latest developments and challenges in the healthcare sector. ? ?? Gregorios Michailopoulos, Managing Partner at MICHAILOPOULOS & ASSOCIATES LAW FIRM will elaborate on 'The role of the public sector in Healthcare Procurement: New strategic directions and tools'. ??This session is packed with valuable insights and perspectives for legal professionals and field practitioners. ? The conference is held under the auspices of the Hellenic Association of Pharmaceutical Companies ( ΣΦΕΕ / SFEE - Σ?νδεσμο? Φαρμακευτικ?ν Επιχειρ?σεων Ελλ?δο?), the Hellenic Association of Medical Technology Companies (ΣΕΙΒ / SEIV - Σ?νδεσμο? Επιχειρ?σεων Ιατρικ?ν & Βιοτεχνολογικ?ν Προ??ντων) and the Hellenic Investors and Internet Association (Hellenic Investors Association). ? ?? We look forward to seeing you! ???For further information please click on: https://shorturl.at/wqHtU #HealthcarePolicy #LegalForum #HealthEconomics #PharmaceuticalLaw #CompetitionLaw #Δ?καιοΥγε?α? #Publiclaw #michailopoulosandassociates #nomikivivliothiki

On September 18, 2024, the Law “On Amendments to Certain Laws of Ukraine on the Settlement of Certain Issues in the Fields of Healthcare, Rehabilitation, Social Protection and State Registration of Certain Objects of Sanitary Measures” came into force, which will be enacted on December 18, 2024. Our experts of Life Sciences & Healthcare practice spoke about the updated obligations and restrictions for medical, pharmaceutical and rehabilitation professionals. Read Legal Alert via the link: https://lnkd.in/erTn5Q7n #alert #legalalert #arzinger #law #lawfirm

The Medical Research Act has been received with mixed feelings, with responses varying from criticism to praise. Gain insights into the ongoing debate as well as the opportunities and challenges the industry anticipates with this law. Our Head of Regulatory Affairs, Sascha Herzer, offers a personal perspective on how his work at a #CRO will be affected. Download our latest #Whitepaper about the Medical Research Act now at the link below! DE: ??https://lnkd.in/etk8hBgQ EN: ??https://lnkd.in/egb8szva #MedicalResearchAct #Medizinforschungsgesetz #MFG #ClinicalTrials

#BusinessLawToday | Potential buyers of clinical trial sites must understand the complex legal and regulatory challenges involved, such as corporate practice of medicine rules. Read: https://lnkd.in/epR6rPFa #MergersandAcquisitions #BusinessRegulation #RegulatedIndustries

In pursuit of more affordable and accessible health care, Congress is considering legislation that would destabilize patent law and actually lead to research, development, and availability of fewer, more expensive medicines. More in Bloomberg Law here: https://lnkd.in/eR8vQc82

Reducing bureaucracy while accelerating approval procedures for clinical trials are the main focal points of the planned Medical Research Act. But what does an expert think about this new draft bill? Sascha Herzer, Head of #Regulatory Affairs at Alcedis, sees several advantages for the success of clinical trials due to shorter and more precise timelines and an improved notification procedure, but the contractual freedom in German Federal Law puts a hold on the planned standard contractual clauses for now. Click the link below to read our #blog article about the Medical Research Act and Sascha Herzers standpoint on the draft bill. ?? https://lnkd.in/eKf7j8Ce #MedicalResearchAct #ClinicalTrials

#BusinessLawToday | Potential buyers of clinical trial sites must understand the complex legal and regulatory challenges involved, such as corporate practice of medicine rules. Read: https://lnkd.in/ewRuuzPY #MergersandAcquisitions #BusinessRegulation #RegulatedIndustries

#BusinessLawToday | Potential buyers of clinical trial sites must understand the complex legal and regulatory challenges involved, such as corporate practice of medicine rules. Read: https://lnkd.in/dSpuebqp #MergersandAcquisitions #BusinessRegulation #RegulatedIndustries