Medical Professionals
At Recordati Rare Diseases (RRD), we focus on the few - those affected by rare diseases. They are at the core of our planning, our thinking, and our actions.
Within the Medical Affairs department at RRD, our mission is to reduce the impact of extremely rare and devastating diseases by supporting the science of our medicines. RRD Medical Affairs contributes to enhancement of patient care through non-promotional activities with external and internal stakeholders. We focus on the generation and communication of accurate medical and scientific information to empower clinicians regarding the safe and appropriate use of our medicines.
We support and partner with the healthcare community across three therapeutic areas: endocrine (pituitary) disorders, metabolic disorders, and oncologic disorders, including non-malignant hematology and pediatric oncology.
Within our three therapeutic areas, RRD Medical Affairs is focused on the following rare diseases:
- Endocrinology: Pituitary disease, including acromegaly and Cushing's disease
- Metabolism: Cystinosis, Homocystinurias, Organic Acidemias, Urea Cycle Disorders, and Porphyrias
- Oncology: Castleman disease and neuroblastoma; rare dermatologic lymphoma (Canada only)
United States
1-888-575-8344 (M-F 8 AM-6 PM CST) Toll-Free
1-908-787-8050 (M-F 8 AM-6 PM CST)
medinfo@recordatirarediseases.com
US Adverse Event Reporting
1-888-575-8344 (M-F 8 AM-6 PM CST) Toll-Free
1-908-787-8050 (M-F 8 AM-6 PM CST)
RRDpharmacovigilance@recordati.com
Educational Program Grant Policy and Procedure
RRD is committed to supporting Corporate Social Responsibility through our Grants and Donations process. RRD's Medical Review Committee (MRC) will assess the legitimacy of grant requests relating to Educational Programs. Funding support is never intended to induce, incentivize or reward past, current or future prescribing, purchasing, formulary inclusion or reimbursement of RRD products.
Who is eligible to receive support:
The recipient of a grant under this policy must be an independent third party and must retain control over the program's content, faculty, and attendees. Independence in this context is defined as ensuring that all decisions related to the planning, faculty selection, delivery, and evaluation of accredited education are made without any influence or involvement from any commercial interest and all final decisions are made by the recipient of the grant.
What Recordati Rare Diseases is able to support:
Educational Programs are programs or activities primarily dedicated to promoting objective scientific and educational activities, the main incentive for which is to bring attendees together to further their knowledge on the topic being presented. RRD personnel in their actions concerning Educational Programs must comply with all applicable laws, regulations, and RRD policies.
All materials provided to HCPs and/or consumers must be truthful, non-misleading, comprehensive, objective, scientifically rigorous and accurate, properly substantiated, balanced, non-promotional and free of commercial influences, targeted to the specific need, reflecting RRD’s knowledge regarding the product and therapeutic area in question and complying with all applicable laws, including FDA Safe Harbor for Exchange of Scientific Information, 21CFR § 312.7, SEC disclosure, the PhRMA Code and RRD policies and procedures.
What Recordati Rare Diseases is not able to support:
RRD will not reimburse or otherwise pay for the costs of travel, lodging, or other personal expenses of non-faculty HCPs attending Educational Programs, either directly to the individuals participating in the event or indirectly to the event’s sponsor, except in connection with a scholarship grant pursuant to the Corporate Sponsorship Policy. Similarly, RRD will not compensate non-faculty HCPs for expenses incurred participating in Educational Programs and related events.
How to Submit an Educational Grant Request:
Disease Areas of Interest: Endocrinology (Acromegaly, Cushing's Syndrome/disease), Metabolic, and Oncology (Castleman disease, Neuroblastoma)
Submit an educational grant request along with required documentation to educationalgrants@recordati.com
Required Documentation Includes:
- Application
- IRS Documentation Letter of tax-exempt status OR Federal Tax ID Number
- Detailed Budget
- Needs Assessment
- Signed W9
Visiting Professorship Educational Grant Program Request:
RRD will also support specific requests for your organization to invite and host an expert within our disease areas of interest onsite for a one or two day educational program and/or consultation. This program could include things such as grand rounds, case-based conferences, one-on-one meetings with researchers or trainees to discuss clinical research projects in the area of rare diseases. Multidisciplinary activities are encouraged. Please see the Visiting Professorships Grant Program application here.
Submit this Visiting Professorships Grant Program application along with the required documentation to educationalgrants@recordati.com
Investigator Sponsored Studies
Who is eligible to receive support:
Recordati Rare Diseases (RRD) is committed to independent, unsolicited research that advances medical and scientific knowledge about RRD products and generates promising medical research. RRD may provide study drug and/or financial support for Investigator Sponsored Studies (ISS), to the extent approved by its ISS Committee. Support for an ISS will only be provided where such study is intended to meet a legitimate and bona fide medical need.
What Recordati Rare Diseases is able to support:
RRD may support an approved study with funding and/or medicinal product. RRD ensures safety reporting requirements are communicated to the investigator or institution prior to the start of an ISS and as needed during the conduct of the study. RRD ensures that the investigator or institution contact information is available and current for the purpose of distributing safety related information. Any support provided to an ISS will represent fair market value remuneration for the services performed.
How to submit an Investigator Sponsored Study request
Requestors will provide written requests for grants, including budget, to the designated ISS email inbox. Concept submission will be reviewed collectively by RRD’s ISS Review Committee based on scientific merit and alignment with corporate research and development plans.
The requestor will be informed about the outcome, and if the concept submission is approved, then the investigator will be invited to submit a final ISS protocol and budget in order to be considered for full approval. RRD requires that the following documents are in place before ISS support may be provided:
- A fully executed ISS agreement between the sponsor and RRD
- A fully executed ISS safety data exchange agreement between the sponsor and RRD
- An EC/IRB and/or Health Authority approval
For ISS inquiries and submissions please email: investigatorsponsoredstudies@recordati.com