Transparency and Disclosure
PDRadiopharma: Guidelines on Transparency in Relationships with Medical Institutions
1. Corporate Stance
These Guidelines set forth the corporate policy of PDRadiopharma Inc. regarding transparency in relationships with medical institutions, etc., ensuring that all our activities comply with the spirit and provisions of relevant standards--including the "JPMA Charter of Corporate Behavior," "JPMA Compliance Program Guidelines," and "JPMA Code of Practice" established by the Japan Pharmaceutical Manufacturers Association (JPMA), as well as the PeptiDream Group's "Code of Conduct".
We strongly recognize the importance of ensuring transparency in our relationships with medical institutions, etc. in the course of our business activities. With the aim of gaining broad understanding of our contribution to the advancement of life sciences, including medicine and pharmacy, and of ensuring that our business activities are conducted with the highest ethical standards, we disclose the information set forth below.
2. Disclosure method
On our external website, we will publish the amounts and other details regarding funding and other support for the items specified in Section 4 below for the previous fiscal year after the end of that fiscal year.
3. Timing of disclosure
Disclosure will be made within one year after the end of the previous fiscal year.
4. Targets of disclosure
A. Research and development expenses, etc.
Research and development expenses, etc. include expenses required for research/surveillance, etc. conducted under public regulations and various policies such as the Clinical Trials Act and GCP/GVP/GPSP ordinances under the Pharmaceutical and Medical Device Act.
- Specified clinical trial expenses*1 (Name, etc. of the relevant institution, etc.*2: XX cases, XX yen)
- Research expenses based on ethical guidelines*3 (Name of the relevant institution, etc.*4: XX cases, XX yen)
- Research expenses other than clinical trials*5 (Name of the relevant institution, etc.*4)
- Clinical trial expenses (Name of the relevant institution, etc.*4: XX cases, XX yen)
- Post-marketing clinical study expenses (Name of the relevant institution, etc.*4: XX cases, XX yen)
- Adverse drug reaction/infection case reporting expenses (Name of the relevant institution, etc.*4: XX cases, XX yen)
- Post-marketing surveillance expenses (Name of the relevant institution, etc.*4: XX cases, XX yen)
- Other expenses (Annual total amount)
*1) "Specified clinical trial expenses" refer to expenses paid pursuant to a contract for a specified clinical trial as defined in the Clinical Trials Act.
*2) "Clinical trial identification number", "institution, etc. to which funds are provided", "name of medical institution conducting the research" and "name of principal investigator", etc. shall be disclosed.
*3) "Ethical guidelines" as used for the "research expenses based on ethical guidelines" shall mean the "Ethical Guidelines for Medical and Biological Research Involving Human Subjects" (life/medical and health guidelines).
*4) For "name of the relevant institution, etc.", "name of the institution", "name of in-house organization" and "department/title/name of the individual" shall be disclosed based on the contents of the contract.
*5) "Research expenses other than clinical trials" refer to expenses required for research other than a specified clinical trial, research based on ethical guidelines, clinical trials, or post-marketing surveillance, etc., such as the so-called "basic research" and "pharmaceutical research."
B. Academic research support expenses
Scholarship donations and general donations made for the purpose of promoting academic research and subsidizing research, etc., as well as donations to academic societies, etc. to support the costs of holding meetings of academic societies, etc., and expenses for co-sponsorship of academic societies, etc.", include co-sponsorship expenses for seminars, etc., advertising fees, exhibition fees, etc. incidental to the holding of the meeting. Funds etc. provided shall be disclosed as follows together with the annual amount of each item.
- Scholarship donations (XX Department of XX University: Number of Donations, XX yen)
- General donations (XX University (XX Foundation): Number of Donations, XX yen)
- Donations to academic society, etc. (XXth XX Academic Society Meeting (XX Regional Meeting / XX Study Group Meeting): XX yen)
- Expenses of co-sponsored conference, etc. (XXth XX Academic Society Meeting (XX Regional Meeting, XX Study Group Meeting): XX yen
This section includes information required to be disclosed under the Clinical Trials Act.
C. Manuscript/writing fees, etc.
Fees, etc. for provision of scientific information, etc. on our pharmaceutical products, medicine, and pharmacy or fees, etc. paid as consideration for lectures and writing or supervision of the manuscript that are related to research and development, or commissioning of services including consulting contracts, etc.
- Lecturer fees (Professor (Director)XX, XX Department of XX University (XX Hospital): Number of services, XX yen)
- Manuscript writing Fee/supervision Fees (Professor (Director)XX, XX Department of XX University (XX Hospital): Number of services, XX yen)
- Consulting, etc. commissioning fees (Professor (Director)XX, XX Department of XX University (XX Hospital): Number of services, XX yen)
This section includes information required to be disclosed under the Clinical Trials Act.
D. Information provision-related expenses
Expenses of lecture meetings and explanation meetings, etc. for providing information, etc. related to our pharmaceutical products, medicine and pharmacy to medical professionals.
- Expenses for meetings including lectures, etc. (Annual number of meetings and total amount)
- Explanation meeting expenses (Annual number of meetings and total amount)
- Medical/pharmaceutical literature, etc. supply expenses (Annual total amount)
E. Other expenses
Expenses for hospitality, etc. as social courtesy
- Expenses for hospitality, etc. (Annual total amount)
PDRadiopharma Guidelines on Transparency in Relationships with Patient Groups
1. Corporate Stance
These Guidelines set forth the corporate policy of PDRadiopharma Inc. regarding transparency in relationships with Patient Groups, ensuring that all our activities comply with the spirit and provisions of relevant standards--including the "JPMA Charter of Corporate Behavior," "JPMA Compliance Program Guidelines," "JPMA Code of Practice," and "Guidelines for Collaboration with Patient Organizations" established by the Japan Pharmaceutical Manufacturers Association (JPMA), as well as the PeptiDream Group's "Code of Conduct".
We strongly recognize the importance of ensuring transparency in our relationships with patient groups in the course of our business activities. With the aim of fostering broad understanding that our business activities contribute to the activities and development of patient groups while ensuring a high level of ethics and mutual understanding that respects the independence of such organizations, we disclose the information set forth below.
2. Disclosure method
On our external website, we will publish the amounts and other details regarding funding and other support for items specified in Section 4 below for the previous fiscal year after the end of that fiscal year.
3. Timing of disclosure
Disclosure will be made within one year after the end of the previous fiscal year.
4. Targets of disclosure
(1) Direct funding
(Target) Donations, membership and sponsoring membership fees, sponsorship fees, advertising fees, etc.
(Details) Names of patient groups that received direct funding and the amounts by expense category.
(2) Indirect funding
(Target) Expenses associated with lecture meetings, explanation meetings, training sessions, etc., organized or co-organized by us for the purpose of supporting patient groups
Expenses outsourced to external vendors in connection with support for patient groups
(Details) Names of patient groups that received indirect funding and the total amount of indirect funding
(3) Honorarium, etc. for services requested by us
(Target) Expenses for lecturers, manuscript writing and supervision, research, advisors, etc.
(Details) Names of the patient groups commissioned by us and the amounts for each expense category.
(4) Other
(Target) Whether labor services were rendered.
(Details) Names of the patient groups to which services were provided.