We are excited to announce an upcoming live seminar on the Medical Devices Regulatory Framework (MDR & IVDR) and the latest updates on the AI ACT. With continuous changes in the regulatory landscape for medical devices and the participation of numerous companies, research centers, and universities in European and national funding programs such as Research Innovate – HORIZON and ESPA, this seminar is of great value to all.

Live 4-hour Training Course on the Medical Devices Regulatory Framework (MDR & IVDR) Pytheia,

The leading Competence Center in Greece in the field of Health, Pytheia in collaboration with the specialized legal office Michalopoulou & Associates Lawgroup and the educational organization EUROPROODOS, is organizing an official seminar that provides essential knowledge required before conducting any research or development of Medical Devices and Software as Medical Devices.

Seminar Details: Date: Monday, May 29, 2023 Time: 17:00-21:00 Location: Academy 98-100, Athens, EUROPROODOS educational organization

Who Should Attend:

This course is designed for all stakeholders in the medical technology supply chain, including manufacturers, distributors, medical technology product executives, researchers, start-ups, pharmaceutical companies, IT companies active in medical applications, irrespective of department and specialty. The seminar encourages lifelong learning and facilitates greater interaction among professionals in the sector.

Topics Covered: During the seminar, we will cover a range of subject areas, including:

1. Introductory information: basic definitions under MDR/IVDR.
2. MDR vs AI Act: Challenges & contrasts between the MDR and the proposed new Regulation on Artificial Intelligence.
3. Transitional provisions and validity of certificates.
4. The case of Greece – Legislative framework.
5. Medical Devices vs. Medicines.
6. Medical Device as Software: Definitions, Characteristics, and classification, marketing and conformity assessment of MDSWs, individual MDSW modules, program changes.
7. Medical Device as Software: Clinical Documentation and Clinical Evaluation.
8. Cyber Security and MDR/IVDR Issues.
9. Obligations of economic operators under MDR/IVDR and the role of PRRC (person responsible for regulatory compliance).
10. Security Issues including UDI, EUDAMED.
11. Responsibilities and Role of Notified Bodies.
12. Scope, subject MDR/IVDR → Regulations, purpose, key changes, classification of medical devices.
13. Comprehension Quiz.
14. Conclusions and areas of concern-Questions.

The course will also touch on the announcements and contrasts between the MDR and the proposed new regulation on artificial intelligence, followed by a quiz to test understanding, and concluding remarks.

Registration:

To secure your spot, we encourage you to pre-register today, as the registration will close after reaching 50 entries. The participation fee is 150 euros. A special certificate will be awarded to attendees of this seminar.

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This action is co-financed by EPANEK (European Regional Development Fund of the European Union and national resources) through the General Secretariat for Research and Innovation (GSIC). We aim for maximum participation to ensure comprehensive training registrations.

To create awareness and promote the seminar, we have prepared three social media posts for Facebook and Instagram. Researchers and potential seminar attendees are listed in the article. Stay tuned for these posts, and please help us spread the word.

Thank you, and we look forward to seeing you at the seminar!

Sincerely, Sotiris Anagnostis/ Manager @Pytheia Competence Center

The post Join Our Live Seminar on MDR & IVDR Medical Device and Drug Regulatory Framework and AI ACT Update appeared first on Pytheia Competence Center.

Summary

Neurodegenerative disease among male elite Swedish football players: a cohort study

Background

Football (soccer) players might be at increased risk of neurodegenerative disease. Which has led to questions regarding the safety of the sport and recent measures introduced by football associations to reduce heading of the ball. We aimed to assess the risk of neurodegenerative disease among male football players in the Swedish top division Allsvenskan, compared with matched controls.

Source: The Lancet Public Health

Methods

In this cohort study, we identified all male football players (amateurs and professionals) who had played at least one game in Allsvenskan from Aug 1, 1924 to Dec 31, 2019 and excluded players whose personal identity number could not be retrieved or be identified in the Total Population Register, and those who were not born in Sweden and who had immigrated to the country after age 15 years. Football players were matched with up to ten controls from the general population according to sex, age, and region of residence. We used nationwide registers to compare the risk of neurodegenerative disease (diagnoses recorded in death certificates, during hospital admissions and outpatient visits, or use of prescription drugs for dementia) among football players versus controls. We also assessed each type of neurodegenerative disease (Alzheimer’s disease and other dementias, motor neuron disease, and Parkinson’s disease) separately, and compared the risk of neurodegenerative disease among outfield players versus goalkeepers.

Findings

Of 7386 football players who had played at least one game in the top Swedish division between Aug 1, 1924, and Dec 31, 2019, 182 players were excluded for an unretrievable personal identity number, and 417 were excluded due to their number not being identified in the Total Population Register. After a further exclusion of 780 players and 11 627 controls who were born outside of Sweden and who had immigrated to the country after age 15 years, 6007 football players (510 goalkeepers) were included in the study population along with 56 168 matched controls. During follow-up to Dec 31, 2020, 537 (8·9%) of 6007 football players and 3485 (6·2%) of 56 168 controls were diagnosed with neurodegenerative disease. The risk of neurodegenerative disease was higher among football players than controls (hazard ratio [HR] 1·46 [95% CI 1·33–1·60]). Alzheimer’s disease and other dementias were more common among football players than controls (HR 1·62 [95% CI 1·47–1·78]), significant group differences were not observed for motor neuron disease (HR 1·27 [0·73–2·22]), and Parkinson’s disease was less common among football players (HR 0·68 [0·52–0·89]). The risk of neurodegenerative disease was higher for outfield players than controls (HR 1·50 [95% CI 1·36–1·65]) but not for goalkeepers versus controls (HR 1·07 [0·78–1·47]), and outfield players had a higher risk of neurodegenerative disease than did goalkeepers (HR 1·43 [1·03–1·99]). All-cause mortality was slightly lower among football players than controls (HR 0·95 [95% CI 0·91–0·99]).

Interpretation

In this cohort study, male football players who had played in the Swedish top division had a significantly increased risk of neurodegenerative disease compared with population controls. The risk increase was observed for Alzheimer’s disease and other dementias but not for other types of neurodegenerative disease, and among outfield players, but not among goalkeepers. Our study expands on the data that can be used to assess and manage risks in the sport.

Funding

Karolinska Institutet, The Swedish Research Council for Sport Science, Folksam Research Foundation, Hedberg Foundation, Neurofonden, and Åhlen Foundation.

FIND THE SURVEY AND THE SOURCE OF THIS ARTICLE HERE

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The post The Risk of Soccer: A New Study Reveals Alarming Results” appeared first on Pytheia Competence Center.