Privacy notice for students attending Biosimilars Forum

Dear participants,

Thank you for your interest in our Annual Biosimilars Forum! This page has been designed for the purpose of providing information to you about our data protection as required by the EU General Data Protection Regulation (Regulation (EU) 2016/679, hereinafter referred to as the „GDPR”).

We at Accelsiors are committed to protecting your privacy and with that in mind, we have developed our ’Privacy Notice for Students’ to make it easier for you to understand what information we collect, why we collect it and how we use it to clarify how you can make choices about your information and the measures we have put in place to keep your information secure.

If you have any questions about these data protection rules, please contact us by using the contact information provided below.

Privacy Notice for Students

This notice applies to information held about you in connection with our Annual Biosimilars Forum (“Forum”) by members of the Accelsiors Group as data controllers, as described below. It explains what information we collect about you in connection with your registration to the Forum, how we’ll use that information, who we’ll share it with, the circumstances when we’ll share it, and what steps we’ll take to make sure it stays private and secure.

1. What information is collected?

The types of data we collect, and process in connection with your registration to the Forum are the data provided by you on our registration form. That includes your:

• Name;
• Email addresses;
• Job title (if any);
• Data related to special diet required by you (if any);
• Phone number;
• Your billing address;
• Information about your study programme (Name of the University, Faculty, Title of study programme);
• Your Student Card Number.

2. How was my data collected?

Any data regarding your registration and our communications is recorded by Accelsiors directly.

3. What is the purpose for collecting my data? What will my data be used for? What is the basis for processing my data?

Your personal data will be used to set up your contact in our Client Relationship Management („CRM”) system which enables us to manage our interaction with you to provide information on the Forum.

The legal basis for processing your personal data is the performance concluded between you and Accelsiors in connection with the Forum. Also, some data may be processed even after the conclusion of the Forum based on the legitimate interest of Accelsiors.

4. Processing your data for marketing purposes

If you provide us with your consent, we will make contact with you for marketing purposes through any particular contact info provided by you through the registration sheet (such as email, telephone or post). However, if you do not give us your consent, or you withdraw such consent at any time, we will not make contact with you for marketing purposes.

5. Data processing of images captured of you during the event

By accepting the present notice, you give permission for images of you, captured during the conference through photo, video, and/or digital camera, to be used by the Organizers of the Annual Biosimilars Forum in promotional materials, publications, and website and waive any and all rights including but not limited to compensation or ownership. You may revoke such permission at any time, in which case – unless Organizer have a legal basis other than your consent for the processing of such data – the images captured of you will be deleted.

6.  Who will control my data?

The data is being collected and controlled by Accelsiors Kft. (hereinafter referred to as “Accelsiors”), a Hungarian company with its headquarters in Budapest, Miskolci Street, no. 50. with the contact information as follows:

• Contact address: 103 Haros street, 1222, Budapest, Hungary., T: +36-1-299-0091, Fax: +36-1-299-0096
• Accelsiors’ Data Protection Officer can be contacted at [email protected].

7.  Will my data be protected?

At Accelsiors, we are committed to protecting your privacy. Accelsiors is a company established in the European Union and, consequently, your study data will be processed in accordance with the applicable European Union law. Your personal data will be recorded in our secure CRM system.

8.  Who will receive my data? Will my data be processed outside of the European Union?

Accelsiors will share your personal data only with its affiliates and/or agents/service providers. Your personal data will be transferred to its affiliates outside of the European Union only if either:

1. The European Commission has adopted an adequacy decision regarding the territory in which the company is established and to which your personal data will be sent, ensuring an adequate level of protection;
2. The receiving company has signed an agreement containing standard data protection clauses adopted by the European Commission which ensures an adequate level of protection for your personal data.

9. How long will my data be kept?

Accelsiors will keep your personal data for a period of 5 years from the conclusion of the Forum.

10. How to access and control my personal data? What rights do I have in relation to my personal data?

You have the following rights in relation to the processing of your data:

• You can request access, correction, updates or deletion of your personal information.
• You have the right to be informed which of your personal data are being processed, as well as the details regarding the processing. You may request a copy of your personal data that is being processed.
• You have the right to rectify any inaccurate personal data being processed, as well as the right to update any incomplete personal data.
• If you withdraw your consent, you will have the right to ask Accelsiors to erase all of your personal data.
• If you withdraw your consent or if Accelsiors no longer needs to process your data for the purpose they were collected for, you have the right to ask Accelsiors to keep your personal data, while restricting their use, without them being erased.
• You can ask Accelsiors that any information provided by you be communicated back in a structured, commonly used and machine-readable format or ask that such data be transmitted to another Data Controller. The exact format of the data will depend on the data that was collected from you and the way it was used.
• You have the right to complain to a data protection authority about our collection and use of your personal information. You may contact either the supervisory authority of your place of residence if you are a resident of the European Union, or the Competent Authority of Accelsiors’ main establishment: the Hungarian National Authority for Data Protection and Freedom of Information (Nemzeti Adatvédelmi és Információszabadság Hatóság).

To exercise any of these rights, please contact us at [email protected], or by mail to Accelsiors, Ltd., 103 Haros street, 1222, Budapest, Hungary, Attention: Privacy. We will respond to your request within a reasonable timeframe and notify you of the action we have taken.

Short course   /   4th Annual Biosimilar Forum  /   Budapest, 17 October, 2019

Title:

Robust methods for assessment of average and scaled average bioequivalence

Presenters:

• Robert Schall, Department of Mathematical Statistics and Actuarial Science, University of the Free State, South Africa
• Divan Burger, Department of Statistics, University of Pretoria, South Africa

Summary:

The short course presents robust methods for the assessment of both average and of scaled average bioequivalence, based on data from conventional cross-over studies and replicate design cross-over studies. Initially, in an empirical study of a large number of average bioequivalence studies, the results of the (i) classic, (ii) conventional nonparametric and (iii) Bayesian robust analyses are compared, and the need for robust analyses is discussed. Thereafter, the classic and Bayesian robust methods are applied to a group of replicate design bioequivalence studies, and diagnostic plots and outlier diagnostics for such studies are presented. Robust analysis of replicate design bioequivalence data affects not only the estimation of the location parameters of the test and reference formulations, but also the within-reference scaling factor; a proposal is made for the appropriate handling of this matter. The proposed Bayesian robust methodology is flexible with regard to study design (conventional cross-over, replicate design cross-over, parallel design) and with regard to the handling of outliers and skewness in the data.

Privacy notice for business partners attending Biosimilars Forum

Dear current or prospective business partner,

Thank you for your interest in our Annual Biosimilars Forum! This page has been designed for the purpose of providing information to you about our data protection as required by the EU General Data Protection Regulation (Regulation (EU) 2016/679, hereinafter referred to as the „GDPR”).

We at Accelsiors are committed to protecting your privacy and with that in mind, we have developed our ’Privacy Notice for Business Partners’ to make it easier for you to understand what information we collect, why we collect it and how we use it to clarify how you can make choices about your information and the measures we have put in place to keep your information secure.

If you have any questions about these data protection rules, please contact us by using the contact information provided below.

Privacy Notice for Business partners

This notice applies to information held about you and your delegates registered to our Annual Biosimilars Forum (“Forum”) by members of the Accelsiors Group as data controllers, as described below. It explains what information we collect about you and individuals who are connected to your business in connection with your registration to the Forum, how we’ll use that information, who we’ll share it with, the circumstances when we’ll share it, and what steps we’ll take to make sure it stays private and secure.

1. What information is collected?

The types of data we collect, and process in connection with your registration to the Forum are the data provided by you on our registration form. That includes:

• Name of your delegates and the responsible person for registration;
• Email addresses of your delegates and the responsible person for registration;
• Job title of your delegates;
• Data related to special diet required for your delegates (if any);
• Phone number of the person responsible for the registration.

2. How was my data collected?

Any data regarding your registration and our communications is recorded by Accelsiors directly. 

3. What is the purpose for collecting my data? What will my data be used for? What is the basis for processing my data?

The personal data of your delegates will be used to set up your contact in our Client Relationship Management („CRM”) system which enables us to manage our interaction with you and your delegates to provide information on the Forum.

The legal basis for processing your personal data is the performance concluded between you and Accelsiors in connection with the Forum. Also, some data may be processed even after the conclusion of the Forum based on the legitimate interest of Accelsiors, since this type of processing may help Accelsiors to contact potential study Sponsors with the hope of a successful cooperation in conducting clinical trials.

4. Processing your data for marketing purposes

If you provide us with your consent, we will make contact with you for marketing purposes through any particular contact info provided by you through the registration sheet (such as email, telephone or post). However, if you do not give us your consent, or you withdraw such consent at any time, we will immediately stop making contact with you for marketing purposes.

5.  Who will control my data?

The data is being collected and controlled by Accelsiors Kft. (hereinafter referred to as “Accelsiors”), a Hungarian company with its headquarters in Budapest, Miskolci Street, no. 50. with the contact information as follows:

• Contact address: 103 Haros street, 1222, Budapest, Hungary., T: +36-1-299-0091, Fax: +36-1-299-0096
• Accelsiors’ Data Protection Officer can be contacted at [email protected].

6.  Will my data be protected?

At Accelsiors, we are committed to protecting your privacy. Accelsiors is a company established in the European Union and, consequently, your study data will be processed in accordance with the applicable European Union law. Your personal data will be recorded in our secure CRM system.

7.  Who will receive my data? Will my data be processed outside of the European Union?

Accelsiors will share your personal data only with its affiliates and/or agents/service providers. Your personal data will be transferred to its affiliates outside of the European Union only if either:

1. The European Commission has adopted an adequacy decision regarding the territory in which the company is established and to which your personal data will be sent, ensuring an adequate level of protection;
2. The receiving company has signed an agreement containing standard data protection clauses adopted by the European Commission which ensures an adequate level of protection for your personal data.

8. How long will my data be kept?

Accelsiors will keep your personal data for a period of 5 years from the conclusion of the Forum.

9.      How to access and control my personal data? What rights do I have in relation to my personal data?

You have the following rights in relation to the processing of your data:

• You can request access, correction, updates or deletion of your personal information.
• You have the right to be informed which of your personal data are being processed, as well as the details regarding the processing. You may request a copy of your personal data that is being processed.
• You have the right to rectify any inaccurate personal data being processed, as well as the right to update any incomplete personal data.
• If you withdraw your consent, you will have the right to ask Accelsiors to erase all of your personal data.
• If you withdraw your consent or if Accelsiors no longer needs to process your data for the purpose they were collected for, you have the right to ask Accelsiors to keep your personal data, while restricting their use, without them being erased.
• You can ask Accelsiors that any information provided by you be communicated back in a structured, commonly used and machine-readable format or ask that such data be transmitted to another Data Controller. The exact format of the data will depend on the data that was collected from you and the way it was used.
• You have the right to complain to a data protection authority about our collection and use of your personal information. You may contact either the supervisory authority of your place of residence if you are a resident of the European Union, or the Competent Authority of Accelsiors’ main establishment: the Hungarian National Authority for Data Protection and Freedom of Information (Nemzeti Adatvédelmi és Információszabadság Hatóság).

To exercise any of these rights, please contact us at [email protected], or by mail to Accelsiors, Ltd., 103 Haros street, 1222, Budapest, Hungary, Attention: Privacy. We will respond to your request within a reasonable timeframe and notify you of the action we have taken.