Radiation liability insurance

From a risk management perspective, it is essential to create a common risk awareness in the first step, which is largely supported by the risk strategy. Convince your investors in the due diligence process of your next financing round with a risk report and a deep understanding of your risks, thereby safeguarding against risks that could threaten your company's existence.

On the basis of sound risk and insurance management, we develop a decision-making basis for your company. You decide what to insure and what not to insure. Because not every risk is worth insuring. Here is our basic approach:

• Risk identification in joint risk workshops, coupled with our experience in industry-typical risks for life sciences, FinTech, tech companies and venture capital firms
• Risk analysis and assessment (software supported on request)
• Development of a joint risk management strategy (Which risks can be accepted, avoided, reduced or transferred?)
• Determination of your company's risk-bearing capacity and risk acceptance and impact analysis on KPIs in your balance sheet (how much risk can you afford or do you want to take?)
• Creation of an insurance strategy (what risk should be borne by the company, what should be insured? Goal: Minimization of risk premiums)
• Implementation and placement of risk and insurance strategies on the insurance market

Your added value through active risk and insurance management:

• Sustainably increase the security level for your company
• Value-oriented risk management will boost your valuation in the next financing round
• Significantly reduce your insurance costs
• Manage and process claims more efficiently
• CONSCIOUSLY take risks and promote growth!

The importance of this for young growth companies was demonstrated not least by the Silicon Valley Bank case, which was identified as part of a risk management process and - if necessary - would have led to an adjustment of the banking/treasury strategy.

(1) Anyone who uses radioactive substances or ionizing radiation on human beings for the purpose of medical research shall require approval, unless the use of radioactive substances or ionizing radiation on human beings for the purpose of medical research is subject to notification pursuant to Section 32 (1). Approval is also required for anyone who deviates significantly from an application approved in accordance with this provision.

(2) The application for approval shall be accompanied by the documents required for examination.

(3) The competent authority shall check the documents required for the examination for completeness within 21 calendar days of receipt of the application for approval. If the documents are incomplete, the competent authority shall request the applicant to rectify the deficiencies it has identified within 21 calendar days of receipt of the request. The competent authority shall decide on the application for approval within 90 calendar days of receipt of the complete application documents. The competent authority may extend the deadline by 90 calendar days if this is necessary due to the difficulty of the examination. The extension of the deadline must be justified and communicated in good time. The permit shall be deemed to have been granted if the competent authority has not made a decision on the permit application within the extended period.

(4) The competent authority may only grant approval if

1. the radiation-related risks associated with the application for the person included in the research project are medically justified in terms of the anticipated significance of the results for the further development of medical examination methods or treatment procedures or medical science, taking into account the medical benefit for the person, if applicable,
2. the radioactive substances or types of application of ionizing radiation intended for medical research correspond to the purpose of the research project and cannot be replaced by other types of examination and treatment that result in no or less exposure for the person,
3. the exposure occurring during use and the activity of the radioactive substances to be used cannot be further reduced according to the state of the art in science and technology without jeopardizing the fulfilment of the purpose of the research project,
4. the number of persons included in the research project is limited to what is necessary to fulfill the purpose of the research project,
5. an ethics committee has issued a favorable opinion on the research project in accordance with Section 36,
6. the applications are supervised by a physician who has the required expertise in radiation protection and at least two years of experience in the application of radioactive substances or ionizing radiation to humans,
7. the necessary provisions have been made for the fulfillment of statutory compensation obligations and
8. an authorization according to § 12 paragraph 1 numbers 1 to 4 for use on humans exists or the operation of an X-ray device notified for use on humans according to § 19 paragraph 1 is permitted.

1. in the case of installations and activities for which liability is determined in accordance with the Paris Convention in conjunction with Article 25 paragraphs 1 to 4, Article 25a, one of the international treaties referred to in Article 25a paragraph 2 or Article 26 paragraph 1 in conjunction with paragraph 1a, be proportionate to the hazardous nature of the installation or activity; where liability is determined in accordance with the Paris Convention in conjunction with Article 25 paragraphs 1 to 4, the financial security may not be less than the amounts specified in Article 7 paragraphs a and b of the Paris Convention,
2. in other cases of an activity that requires authorization on the basis of this Act or on the basis of an ordinance issued under this Act, ensure the fulfillment of statutory compensation obligations to the extent required by the circumstances.

Good Clinical Practice (GCP) is an internationally recognized ethical and scientific standard for the planning, conduct, documentation and reporting of human clinical trials. Compliance with this standard creates public confidence that the rights, safety and welfare of the subject will be protected in accordance with the principles set out in the Declaration of Helsinki. Measures must also be taken in the event of harm to the trial participant as a result of the clinical trial. This is ensured by taking out the right insurance and by providing additional health care.