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European medical information and product safety

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Healthcare professionals, patients, and caregivers may request specific product and/or program information from Medical Information. At this time, we are able to offer support in English, French, and German.

Privacy notice

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What

Seagen B.V. (“Seagen”) will electronically process and store the following categories of personal data in its systems: 

personal details (eg, name, gender, date of birth), contact details (eg, email address, telephone number(s), country), professional qualifications, institute and other professional affiliations (egdepartment, function, specialty). 

If you contact us to ask for information on our products or to report an adverse event, we may also collect information about your health or other sensitive data. 

This information is only processed when relevant and necessary to document your reaction properly and for the purpose of meeting our pharmacovigilance, safety, and any other legal requirements. 

Why

In case of a medical enquiry, your personal data may be used to answer your inquiry, follow up on said request, and maintain the information in a medical information database for reference. 

In case of an adverse event reporting, we need to be able to get in touch with people who contact us in order to follow up and, if needed, obtain further information, give answers to requests, or to send requested material. 

In case of communications about our products, the information will be used only for that purpose (eg, evaluation, classification and assessment of the product complaint, to follow up on such requests, and to maintain the information in a product complaints database for reference). 

Legal basis

The processing of your personal data will be based on our willingness and obligation to ensure high standards of quality and safety of medicinal products and the articles 6.1(c), 6.1(f) and 9.2(i) of the GDPR (the General Data Protection Regulation 2016/679).

The processing may also be based on your consent to said processing and the article 9.2(a) of the GDPR.

Who

The entity responsible to collect and process your data is SeaGen Netherlands BV, with registered office in Evert van de Beekstraat 1, 140, 1118CL Schiphol (Netherlands).

You can use this address or the email address europedataprotection@seagen.com to contact us.

Since Seagen is a part of an international group of companies and some of them perform services for us, SeaGen may also have to transfer your data to companies of the Seagen group.

SeaGen may also have to share your data with services providers (eg, Medical Information Call Centers).

In cases when an adverse event is reported, we will have to share your data with health authorities (such as the European Medicines Agency) to allow them to evaluate adverse events and make efforts to prevent similar events from happening in the future. However, note that in these circumstances we do not share any information that directly identifies any individual (such as names or contact information), but we only share pseudonymised information.

Where

Companies of the Seagen group or service providers may be located in Switzerland or countries of the EEA (European Economic Area).

We may also have to transfer your data to our parent company in the U.S.: this will happen regularly for pharmacovigilance purposes, while only occasionally in case of medical enquiries or product complaints.

The U.S. is among those countries that are not considered by the EU Commission as offering adequate protection to personal data, that is to say that, according to the Commission, the data processing measures adopted in the U.S. are not as secure as the one adopted in the EEA.

When we transfer personal data out of the EEA to other countries that have not been deemed adequate, SeaGen ensures that this will only happen in compliance with the law and with appropriate safeguards pursuant to art. 49.1(a) GDPR.

For how long

For adverse reporting, in accordance with law, pharmaceutical companies, as market authorisation holders of products, must retain all product-related documents for at least the time period of the market authorisation, plus 10 years following its expiry. Therefore, personal information related to the safety of our products will be retained for this time period.

For medical information enquiries and product complaints, personal information will be retained for a maximum of 5 years from the moment of collection.

What are your rights

You may be entitled under applicable law to ask SeaGen for a copy of your information, to correct it, or erase or restrict its processing. You may also have rights to object to some processing and withdraw your consent where applicable, however these rights may be limited in some situations – for example, where we have a legal requirement to process or keep your personal data.

Please note that, for legal reasons, we cannot delete information that has been collected as part of an adverse event report unless it is inaccurate. Also, we may require you to provide proper identification before we comply with any request to access or correct personal data.

You can exercise your rights by using the email address europedataprotection@seagen.com.

Supervisory authority

We wish to remind you that you can lodge a complaint with your country’s Data Protection Supervisory Authority, should you have legitimate reasons to complain about the processing of your data by SeaGen.


Medical Information contact centre hours

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For support in English

Monday to Friday
9:00 – 17:00 GM

For support in French or German

Monday to Friday
9:00 – 17:00 CET

Please note that our offices will be closed on January 1; March 3; April 10, 13, 17, and 20; May 1, 6, 8, and 25; August 31; September 7 and 24; and December 24, 25, and 28.

Phone numbers by country

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Report a side effect

Patient safety is of the utmost importance to Seagen. To provide better safety information for our medicines, we monitor side effects continuously in clinical trials and after bringing a therapy to market.

Please report any side effects caused by Seagen’s medicines. We may contact you for more information concerning your report.

Seagen is unable to provide medical advice. If you are a patient and are concerned in any way about your treatment, you should contact your healthcare professional.

To report a safety concern

Contact the Medical Information contact centre or email drug.safety@seagen.com


Report a product complaint

Seagen is committed to producing to the highest possible standards. If you have any concerns about the identity, quality, reliability, safety, effectiveness, or performance of a Seagen product, please report them immediately.

To report a complaint

Contact the Medical Information contact centre or email productqualitycomplaints@seagen.com