1. PSUR compilation ("literature PSURs")

The "literature PSUR" includes the following activities on the part of Dr. Ebeling & Assoc. GmbH/Diapharm:

1.1. Literature research in MEDLINE and TOXLINE for the PSUR reporting period.

1.2. Software-aided PSUR completion in the form of a template with in-text comments / remarks.

1.3. Processing of publications that are relevant to the PSUR, focusing particular attention on (suspected) adverse drug reactions (ADRs) and an evaluation of the benefit to risk balance for the active substance with reference to preclinical and clinical studies, reviews, meta-analyses and individual case histories within the scope of the associated authorisation(s).

1.4. Synchronisation of the product information from the companies concerned (information for doctors and patients, where provided), as well as the substance-specific BfArM master texts for SPCs and package leaflets (where available); alternatively SPCs or EMEA Core SPCs, CCSIs.

1.5. Bibliographic master file of the reference literature quoted in the PSUR.

1.6. Preparation of literature-related line listings and summary tabulations no later than 20 days prior to the submission date.

1.7. Provision of the electronic "literature PSUR" embedded in the PSUR template no later than 20 days prior to the submission date.

1.8. Preparation of the project-specific SOPs.

1.9. Incorporation of product-specific information relating into sections 2 (marketing authorisation status), 3 (regulatory authority or MAH actions), 4 (changes to reference safety information) and 5 (patient exposure), where such information is provided.

1.10. Supporting the advisory council to the working group for "Gemeinschaftliche Erstellung of Periodic Safety Update Report (PSURs)".

1.11. Contributing towards informative events and training courses associated with the project.

2. The order of an "Individual PSUR" covers the following additional services with costs on the part of Dr. Ebeling & Assoc. GmbH/Diapharm provided that the corresponding company specific information was made available by the customer:

2.1. Incorporation of product-specific information into sections 2 (Worldwide Market Authorisation Status), 3 (Update of Regulatory Authority or MAH Actions Taken for Safety Reasons), 4 (Changes to Reference Safety Information) and 5 (Patient Exposure).

3. The following supplementary services are available at an extra fee to cover the costs incurred.

3.1. Incorporation of product-specific information available within the company into sections 6 (individual case histories from spontaneous reports, sponsored studies or from health authorities), 7 (sponsored studies) and 8 (other information).

3.2. Incorporation of information provided by the company into line listings and summary tabulations.

3.3. PSUR guidance

3.4. Bibliographic research in other scientific literature databases.

 

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