The processing of personal data of data subjects is governed by Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (“Regulation”) and Act No. 18/2018 Coll. on Personal Data Protection and on Amendments to Certain Acts (“Personal Data Protection Act”).
The purpose of this information is to explain how the company UBIQ events, s. r. o., with its registered office at Karpatské námestie 10A, 831 06 Bratislava, Slovak Republic, ID number: 53 647 947, registered in the Commercial Register of the District Court Bratislava I, section: Sro, file No. 158576/ B (“company”), processes the personal data of data subjects and what their rights under the Regulation and the Personal Data Protection Act are.
Personal data are, in particular, any information related to identified or identifiable natural person who can be determined directly or indirectly, especially by referring to the identifier such as name, identification number, localization data, online identifier or by referring to one or several elements specific for physical, physiological, genetic, mental, economic, cultural or social identity of the respective natural person.
Pursuant to the Regulation and the Personal Data Protection Act, the company acts as a controller in the processing of personal data, i.e., as a person who, alone or jointly with others, determines the purposes and means of the processing of personal data of the data subjects.
The company collects personal data in the following ways:
from publicly available sources, such as public registers and records, including, but not limited to, LinkedIn, Google, YouTube, Facebook, Instagram;
The company collects and processes personal data only to the extent which is necessary for the purpose of the processing. The company adheres to strict standards regarding security and protection of personal data and the rights of data subjects.
The company only processes personal data which are necessary in order to provide the customer with services and customer care, to comply with various legal requirements and also to protect its legitimate interests. The company collects personal data about customers, including potential customers, who are interested in the company’s services or who have given their consent.
The company mainly processes the following categories of customers’ personal data:
Contact details, e.g., address of permanent residence, correspondence address, phone number, e-mail, IP addresses.
Sociological and demographic data, e.g., age, sex, family status, education, employment (position, company).
Other data necessary to comply with legal requirements, application, and proof of legal claims of the company.
Video, audio and audio-visual recordings of events organized by the company.
The company processes personal data on the following legal basis established by the Regulation and the Personal Data Protection Act:
Legitimate interest
The company may process the personal data of data subjects if it be necessary for the legitimate interests of the company or of third parties, except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data. Such legitimate interests of the company are particularly:
recovery claims of the company (for this purpose, the company retains personal data for a maximum of the relevant limitation periods);
protection of property, life and health (for this purpose, the company retains the personal data of persons for as long as is necessary to protect such rights);
improvement of services provided to customers, in particular, providing customer care, resolving complaints, grievances and claims (for this purpose, the company retains personal data for no longer than the company’s legitimate interest exists, in particular during the contractual relationship between the company and the data subject and for the time period which is necessary for the particular improvement of services to be achieved).
Performance of the contract
The company processes personal data of the data subjects for purposes related to the fulfillment of contractual obligations of both parties, in particular, the conclusion, changes and termination of the contract, invoicing, etc. The provision of personal data by the data subject to the necessary extent is a precondition for concluding such contracts. Failure to provide personal data may prevent the company from delivering the goods and services to the data subject. The company will provide the data subject with information on what personal data is necessary for the conclusion of the contract.
The company retains personal data for the purposes of performing the contract for the duration of the contractual relationship between the company and the data subject and the necessary time after its termination. Upon termination of the contractual relationship and settlement of all obligations arising from or related to the contract, the company retains personal data for the necessary time, especially during the expiration of possible claims from the termination of the contractual relationship and settlement of all obligations (including litigation), or for a longer period, if the running of the limitation period is interrupted.
Fulfillment of legal obligation
The company may process personal data, including their provision to state authorities and other persons, if such an obligation arises from the law. Due to the legal obligation, the company may, for example, provide personal data to the Office for Personal Data Protection of the Slovak Republic, the Slovak Trade Inspection, the Ministry of the Interior of the Slovak Republic, law enforcement agencies, tax administrator, district offices or other institutions.
The company processes the customer’s personal data for the purposes of payment, invoicing and bookkeeping, according to the legal obligations arising from the following laws and legal acts, e.g.: Act on accounting, Act on tax administration (tax code), Act on income tax, Act on value added tax, Act on banks, Act on payment services.
Consent given by the data subject
The company processes the personal data of the data subjects on the basis of the consent expressly granted by the data subject, if none of the other legal bases can be applied.
The company retains personal data processed with the consent of the data subject for no longer than the duration of such consent, or until revoked, whichever is the earlier. The data subject has the right to freely withdraw his or her consent to the processing of personal data at any time. If the consent is revoked, the personal data may not be further processed, provided that there is no other purpose of processing based on a different legal basis.
Withdrawal of consent shall not affect the lawfulness of the processing resulting from the consent prior to its withdrawal.
The company can entrust the processing of personal data to a third party, the so-called processors. Processors of the company are, for example, persons who ensure the execution of some marketing activities for the company or accounting/tax services or consulting companies. Processors process personal data for the company exclusively on the basis of a personal data processing contract, which must meet the requirements set by the Regulation and the Personal Data Protection Act, and in such cases the company strictly ensures the protection of the personal data it provides to the processors.
The company does not currently transfer personal data to any processor.
The data subject has the right:
at any time to withdraw the consent to the processing of personal data granted to the company with effects from the moment of withdrawal of consent (“right to withdraw consent”);
If the data subject does not have full legal capacity, his or her rights, in accordance with the Regulation and the Personal Data Protection Act, can be exercised by a legal representative. The rights of the deceased data subject pursuant to the Regulation and the Personal Data Protection Act can be exercised by its close living relative.
The company does not transfer the personal data to persons or international organizations outside the European Union.
With regard to the possible risks of misuse and ensuring the protection of the personal data of the data subjects, the company establishes means of communication by which it is possible to receive and respond to the request of the data subject in relation to his or her personal data that the company processes. The company also takes into account the technical aspects of some rights of the data subject and adapts the means of communication to ensure these rights of the data subject. In case of doubt about the identity of the data subject, the company is entitled to request an additional verification of the identity.
The data subject can exercise its rights in the following ways:
by mail sent to the address of the registered office of the company;
by phone to: +421 902 161 667 (only the right to rectification and the right to withdraw consent).
In order to provide transparent, clear and comprehensible information about the usage of information and personal data of users of its website, the company provides visitors of the website www.ubiqwebinars.com (“Company Web”), in accordance with the provisions of Section 109 (8) of Act No. 452/2021 Coll. on electronic communications, as amended, the following information on the use of data stored in the user’s end device, the so-called cookies (“Cookies”). The company can store or gain access to Cookies on visitor’s device only on the basis of visitor’s verifiable granted consent. Consent is not required for Cookies, which are absolutely necessary to ensure the functioning of the Company Web.
Cookies are small data packages or small text files that are stored on visitor’s device, which the visitor uses to browse the Company Web. Cookies are used to improve visitor’s experience on the website and to ensure some website functionality, for example, they allow the company to identify that visitor visits Company Web repeatedly from his or her device, which allows the company to offer to the visitor a content that corresponds to his or her previous visits. Cookies also allow the company to ensure the proper functioning of the Company Web and thanks to them the company can improve its functionality and services for its visitors.
Cookies can be divided according to the time during which they are stored on visitor’s device or according to the purpose for which they are stored.
Depending on the time for which Cookies are stored on visitor’s device, Cookies can be divided into two basic categories, namely temporary and permanent. Temporary Cookies are used only for the purpose of one specific visit of Company Web. These mainly serve to identify the type of visitor’s device (computer, tablet, mobile phone) when repeatedly loading parts of Company Web within one visit. This improves visitor’s browsing experience. After the website browser is closed, temporary Cookies are removed from the visitor’s device. Permanent Cookies help the company recognize the visitor as a unique user of Company Web and remain stored on visitor’s device until their predetermined validity period expires or until visitor deletes them. In addition, permanent Cookies will enable the company to provide the visitor with personalized content of Company Web on the visitor’s next visit.
In terms of purpose, the company uses Cookies in several ways, based on which these Cookies are divided as follows:
Preferential cookies enable information about the user’s preferred use of the website to be stored – this, for example, is the choice of preferred language.
Marketing cookies enable the personalization of marketing content on the website – these are primarily used to display relevant advertising for the user or website visitor.
The company website also uses the Google Analytics service in connection with cookies. If you are interested in more detailed information about the use of Cookies by this service, visit the Google Analytics webpage.
The company uses Cookies only if the visitor has given its explicit consent to their use through the so-called cookies banner. The company does not use Cookies until the visitor gives such consent. However, consent is not required for Cookies, which are absolutely necessary to ensure the functioning of Company Web.
The visitor can grant, change or revoke his or her consent to the use of individual categories of Cookies at any time in the Cookies settings window (the so-called cookies banner) in the “Details” section. Visitor can reopen this window at any time using the button located in the lower corner of the website.
Please note that due to the settings of Company Web, the rejection to grant consent to the use of some categories of Cookies may affect its functionality and prevent the visitor from using some functions.
Personalized medicine is getting implemented through new treatment modalities. Such individualized approaches create new challenges for drug development, especially in the analytical space. With growing precision medicine successes, a balanced approach between individualization of treatments and standardization of methods and materials will become a driver for the broad success of urgently needed new treatments.
• Scarcity of material for analysis
• Representative analysis for therapeutic cells
• Can cell-based therapies be scalable?
Anka Ehrhardt
Director, Cell-Based Sciences
Merck
Fill in the details below to watch the recorded panel discussion:
Personalized healthcare is the next evolution of how we deliver outcomes to patients. We are moving away from treating diseases and towards treating people and bringing outcomes that matter to them. Key to unlocking the promise of personalized healthcare is community involvement… community leadership. This discussion talks about ways in which community-led innovation can bring about the transformation of healthcare towards a more human-centered, personalized approach.
– The value of first-mile health and important role that a community plays
– The value of community-led innovation to a pharmaceutical company’s innovation cycle
– How we can leverage the community to help us innovate our business?
Michael Duong
Head of Innovation
Hoffmann-La Roche Ltd.
New drug approvals for asthma, COPD and other chronic common diseases remain low. Taking a Precision Medicine approach to find the Right Patient will be part of the solution but current examples remain firmly aligned to oncology. By leveraging the worlds genomic data to find new targets and precision medicine strategies, exploiting large phenotyped patient cohorts to understand disease drive and heterogeneity, and accessing target tissue non-invasively to enable longitudinal monitoring of disease activity and drug response, we can change the target paradigm and link the right target to the right patient from the start and finally bring Precsion Medicine to the Respiratory and Immunology therapeutic area.
– New drug approvals for asthma, COPD and other common diseases remain low
– Taking a Precision Medicine approach to find the Right Patient is part of the solution
– By leveraging the worlds genomic data, exploiting large phenotyped cohorts and accessing target tissue non-invasively, we can change the target paradigm, linking the right target to right patient from the start
Adam Platt
Vice President and Head of Translational Science and Experimental Medicine, Research and Early Development, Respiratory and Immunology (R&I), BioPharmaceuticals R&D
AstraZeneca
The relationship of digital innovation in healthcare and the rise of empowered patients is closely tied.
In order to really make an impact in healthcare patient partnership is key and collaborating and understanding patients early is a key to interesting worthwhile innovation. Leading with technology and with human experience is wrong.
In the talk we will go to the origins and meaning of patient participation and see how it develops in different part of healthcare to support growth and innovation
Uri Goren
Head of Marketing and Customer Experience
Novamed
As one of the world’s fastest growing investment sectors, digital health has witnessed a more than 84% growth in venture funding from $31 billion to $57 billion 2021. United States and European countries are two major markets which occupy over 90% market share.
Within the industry, the number of the new entrants also has a significant increase, the funding and market impact have remarkable enlarge during last year. Several factors are converging to spur investments in those high potential unicorns, this speech will go through four major digital health segments: Telehealth& telemedicine, Mobile Health, Wearables and Healthcare Analytics & Health Information technology to see what makes a digital health unicorn.
Dominick Kennerson
Global Head G4A – Digital Health Partnerships
Bayer
This session will focus on:
Vivek Thakkar
Regulatory Program Director – Personalized Healthcare – Digital Health
Genentech
Multiple myeloma (MM) is a clonal hematopoietic disorder
characterized by proliferation of clonal malignant plasma cells in the
Bone Marrow microenvironment, monoclonal protein in the blood or
urine and associated with organ dysfunction.
Despite advances in therapy, MM remains an incurable malignancy,
and most patients eventually become refractory to currently available
treatments. Only 10% – 15% of patients achieve or exceed expected
survival compared with the matched general population. There is no
single standard of care for R/R MM, and treatment is affected by
several factors, including age, performance status, comorbidities,
and the type, efficacy, and tolerance of the previous treatments,
underlying a strong unmet need for novel treatments for patients with
R/R disease.
In my presentation I will first review the overall portfolio at
Roche/Genentech in the Multiple Myeloma space. Then, since T-cell engaging
therapies represent a novel and promising new mechanism
of action to achieve anti-myeloma activity in patients who are R/R to
existing standard of care therapies, I will discuss in more details the
clinical activity and biomarkers finding for our T cell-dependent
bispecific antibody Cevostamab in R/R MM.
Cedric dos Santos
Director, Head of Multiple Myeloma and
Myeloid malignancies including AML
and MDS, Genentech
Targeting myeloid cells within the tumor microenvironment has
emerged as an area of interest because of data demonstrating that
myeloid cells can inhibit the efficacy of immune checkpoints in
cancer. Differences between mouse and human biology of myeloid
cells are one challenge that makes it difficult to predict efficacy in
humans. We will review ongoing trials that target myeloid cells in
patients and discuss opportunities to understand and target
myeloid cells in patients.
Michelle Kinder
Scientific Director
Incyte
CAR T-cell immunotherapy has achieved remarkable success in
selected haematologial malignancies. However, solid tumours remain
impervious to this therapeutic approach. In this talk, I will present
data from the dose escalation phase of a phase 1 clinical trial in
which panErbB specific CAR T-cells are delivered using the intratumoural
route in patients with relapsed refractory head and neck
cancer. I will also introduce a novel technology designated parallel
CAR which harnesses dual co-stimulation by CD28 and 4-1BB,
enabling superior anti-tumour activity in several pre-clinical tumour
models.
John Maher
Chief Scientific Officer
Leucid Bio
Request the program here:
Vamsi Krishna
Medical Director and Global Safety Officer, Amgen
Pat Baird
Regulatory Head of Global Software Standards, Philips
Randy Horton
Vice President of Solutions and Partnerships, Orthogonal
Yvonne Nanciu
Country Head Pharmacovigilance Germany, Bayer
Covid-19, the first alarming pandemic of the third millennium, has caused global public health and economic crises, necessitating rapid development and deployment of vaccines. The worldwide response has been unprecedented with government, academic, and private partnerships working together, rapidly exchanging information and ultimately changing the traditional, lengthy approaches in vaccinology with new emerging technologies offering a promising solution for faster and more flexible development of vaccine candidates that will positively change the global pandemic preparedness strategy.
The monitoring of adverse reactions associated with vaccination is one of the most important factors in vaccine safety. Although vaccines are among the safest medicines on the market, vaccines are not completely risk-free, and adverse events may occur following vaccination. Careful assessment of any adverse events following immunization is essential to distinguish those that are causally linked to the vaccination from those just coincident in time, in order to prevent vaccine distrust or misperception and to ensure an efficient vaccination campaign especially in the context of a global pandemic.
The objective of this presentation is to critically review the most up-to-date available safety data on different Covid-19 vaccines and vaccine candidates in clinical development, understanding their specifications from the mode of action to effectiveness in the context of a challenging global vaccination campaign.
Alex Bica
Director, Global Clinical Safety and Pharmacovigilance, Global R&D, CSL Behring
Intro: This topic shall cover the digital technologies that have redefined the way how patients access /seek healthcare services and the way how physicians deliver patient care.
Key topics:
1. The power of data and data-driven insights: PHR/EHR
2. Tele medicine: the new way of seeing a doctor
3. Self-monitoring of disease outcomes and safety by patients & real-time reporting
4. Prognosis and disease outcomes monitoring
5. Retention of patients and patient delight/satisfaction thru technology-driven patient care
Karthik Anantharaman
Chief Operating Officer, Roche
While breast cancer care has improved significantly over the past decades, its occurrence still stays very high. In the USA alone 1 in 8 women will be diagnosed with invasive breast cancer this year. Today, care is not always effective, largely a one-size-fits-all approach, and struggling to keep up with demand. How can we leverage digital technological advances in our global fight against breast cancer?
Anirudha Dambal
Vice President, Women’s Health, Siemens Healthineers
Request the program here:
Why is it so difficult to get a patient for a trial? And once recruited, why is it so difficult to keep the patient in the trial and on the study drug? And has the pandemic stirred this up? Let’s look at what discourages patients to get into, and remain in a trial. And with that in mind, what does the ideal patient-centered protocol looks like? Are patient-centricity and regulatory requirements compatible?
*Why is it so difficult to get a patient interested in a trial?
*Why is it so difficult to keep the patient in the trial and on the study drug?
*What discourages patients upfront, and while in the study?
*What does the ideal patient-centered protocol looks like?
*Pandemic mitigation measures
Maarten Boomsma
Clinical Research Director
Sanofi
A robust patient retention strategy of enrolled subjects is essential in clinical trials.
If retention is not adequate, the data set to be evaluated may be insufficient, cause an excessive decrease of statistical power, and/or introduce bias that invalidates the work done.
A different perspective is needed to find new ways to support sites and patients to be motivated to continue participating in the large duration of clinical trials with complex protocols procedures.
Advanced technology offers new interactive content that gives patients a new opportunity to better disease control during the treatment phase. Investigational sites can also easily use the advanced technology by means of a single sign on an integrated platform to save time during their data entries tasks and data review.
The results will be illustrated by means of two different study cases using the same strategy and same technology to explain how important is to take a different outlook to the traditional studies.
What is the problem?
What Sponsor can do to increase patient retention expectations?
Which clinical technologies can support patient-centric and retention approaches?
Quality By Design mobile patient-centric application development.
Which are the challenges to overcome?
Can we measure success?
Diego Herrera
Head of Clinical Data & Information Management
Almirall
In this presentation, the Tufts Center for the Study of Drug Development (Tufts CSDD) will discuss the results of an important global study investigating how clinical research professionals have been impacted by the shift to remote work during the COVID-19 pandemic. The study was conducted by Tufts CSDD in collaboration with the Bill & Melinda Gates Medical Research Institute.
The following topics related to clinical research during the COVID-19 pandemic will be addressed:
– Productivity in the execution of clinical research
– General preparedness and responsiveness of research organizations
– Impact of remote work
– Implications
Maria Florez, M.A., Mary Jo Lamberti
TUFTS
Healthcare providers worldwide are facing burgeoning patient demand and associated costs that challenge the very financial stability of services to patients.
The World Health Organisation (WHO) predicts the cost of managing chronic diseases will be 80% of total healthcare expenditure by 2020, with substantial and continuing growth in the numbers of patients with chronic disease. The current model of care for most nations’ healthcare delivery has changed little over the last half-century, whilst advances in diagnosis, medical knowledge, and health informatics, and associated technologies have grown substantially. The fortress structure of Acute (Hospitals), Primary Healthcare, Mental Health, and Social Care is being transformed into a patient-centric integrated care model.
The application of a closed-loop Telemedicine ecosystem using remote vital signs monitoring and predictive algorithms to manage patients with chronic disease will significantly improve patient outcomes and quality of life whilst substantially reducing costs.
Tackling the Burden of Chronic Disease with Digital Health
Telehealth
Remote patient monitoring
Advanced wearables
Predictive analytics & patient segmentation on the basis of risk
Michael John Miller
Digital Health Technical Advisory Group (DHTAG) Roster of Experts
WHO
Technology has had a transformation role in many business sectors in recent decades—and healthcare is also advancing as we become increasingly connected, leading to exciting new areas in healthcare, such as telemedicine, personalized medicine, and predictive medicine. Digital solutions have also gained prevalence, entering the healthcare space and becoming a part of many digital health programs. At the same time, we are seeing an increase in the use of health data, and artificial intelligence and machine learning are helping us to use this data to positively impact health outcomes.
This talk will discuss experiences entering into the connected care space, the potential of digital health and data science, and the changing role of chatbots and artificial intelligence, social media, and web means for our ability to support patients.
Design and development of connected health experiences
Innovating patient support and patient engagement
Integrating technology and data in a programmatic way
Sander Ruitenberg
Global Digital Health Solutions Head
Novartis
Digital Health has the power to revolutionize healthcare if appropriate regulatory frameworks are in place that support the unique and iterative nature of stand-alone software solutions. This presentation explores some of the key challenges that must be addressed when developing fit-for-purpose regulatory frameworks for software products: determining when software is and is not a medical device, risk-based approaches to classification of software as a medical device (SaMD), and creative regulatory approaches to software change management. A review is also provided of some of the unique approaches to software regulation that global regulatory authorities are exploring or have implemented.
Software use cases in the medical device and pharmaceutical communities
Approaches to determining when software is a medical device
Software as a Medical Device (SaMD) classification and clinical evidence requirements
Approaches to the regulation of AI-based SaMD
Regulator efforts to evolve regulatory frameworks for software products
Nathan Carrington
Head of Digital Health and Innovation
Roche Diagnostics
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