POSTS
31/01/2023
Regulation (EU) no. 536/2014 on Clinical Trials
22/11/2022 Market Surveillance of Medical Devices
01/09/2022 LILLA LINE INTERNATIONAL LICENSING & ACQUISITIONS
04/04/2022 RI-NOTIFICA INTEGRATORI ALIMENTARI 2
05/04/2022 YOLO ECONOMY & WELLBEING
02/02/2022 RI-NOTIFICA INTEGRATORI ALIMENTARI
14/01/2022 RE-START 2022
03/06/2021 COVID AS A SAE IN CLINICAL INVESTIGATIONS
09/02/2021 Clinical Evidence Management
30/11/2020 SELF WELLBEING | body | mind | work | world
26/10/2020 QUALITY STANDARDIZATION | SERVICE SUSTAINABILITY | PEOPLE WELLBEING
01/10/2020 CLINICAL TRIALS MANAGEMENT | Market Networking & Monitoring
06/07/2020 #SDG 2 Treatment of Anaemia | Food Supplement RUBENFLUX®
08/06/2020 REGULATORY COMPLIANCE SERVICES | Smart Wellbeing Modulations
06/05/2020 CLINICAL TRIALS MANAGEMENT | Class III Medical Device
Regulation (EU) no. 536/2014 on Clinical Trials
31/01/2023
After the transition period, from today's date 31 January 2023 all the authorization procedures for clinical trials must compulsorily be requested following the contents of the new Regulation (EU) n. 536/2014 on clinical trials of medicines for human use.
The objective of the Regulation is the harmonization of the European discipline on clinical trials, to guarantee high safety standards for patients/subjects, and to strengthen the collaboration of the Member States. The Regulation introduces a harmonized procedure for evaluating applications for authorization, divided into three phases: validation, evaluation; and decision.
To obtain authorization, the trial promoter must apply the dossier to the interested Member States in which he intends to conduct the trial via EMA's CTIS (Clinical Trials Information System) portal, proposing a Reporting Member State.
We remain available to provide further information on the case and to support Customers in all the steps necessary to obtain positive feedback from EMA.
The objective of the Regulation is the harmonization of the European discipline on clinical trials, to guarantee high safety standards for patients/subjects, and to strengthen the collaboration of the Member States. The Regulation introduces a harmonized procedure for evaluating applications for authorization, divided into three phases: validation, evaluation; and decision.
To obtain authorization, the trial promoter must apply the dossier to the interested Member States in which he intends to conduct the trial via EMA's CTIS (Clinical Trials Information System) portal, proposing a Reporting Member State.
We remain available to provide further information on the case and to support Customers in all the steps necessary to obtain positive feedback from EMA.
Market Surveillance of Medical Devices
22/11/2022
All manufacturers of medical devices (MDs) must minimize the risk posed by their MDs and ensure patient safety. Post-market surveillance is thus mandatory. According to the new MDR (EU 2017/745), systematic monitoring is needed following a precise frequency.
For Class I, Is, Im, and Ir MDs, every 4 years at a minimum (the submission to notified bodies is not required). For Class II MDs a PSUR (Periodic Safety Update report) is required every two years at a minimum (upon request the report must be available to the relevant notified body and competent health authority).
For Class IIb MDs a PSUR is required annually (upon request the report must be available to the relevant notified body and competent health authority).
For Class III MDs and implants a PSUR is required to be submitted annually using the EUDAMED system.
We can for sure assist all manufacturers in such activities; do not hesitate to contact us at info@blymum.com
Image: Oleg Gamulinskiy from Pixabay
For Class I, Is, Im, and Ir MDs, every 4 years at a minimum (the submission to notified bodies is not required). For Class II MDs a PSUR (Periodic Safety Update report) is required every two years at a minimum (upon request the report must be available to the relevant notified body and competent health authority).
For Class IIb MDs a PSUR is required annually (upon request the report must be available to the relevant notified body and competent health authority).
For Class III MDs and implants a PSUR is required to be submitted annually using the EUDAMED system.
We can for sure assist all manufacturers in such activities; do not hesitate to contact us at info@blymum.com
Image: Oleg Gamulinskiy from Pixabay
LILLA LINE INTERNATIONAL LICENSING & ACQUISITIONS
01/09/2022
BLYMUM is proposing the LILLA LINE whole portfolio or eventually single products for international licensing and/or for definitive purchase. In case of products/portfolio acquisition, the product’s formula dossier, product samples, literature dossier, IP transfer (if available), testing dossier (if available), and supporting marketing and training contents are delivered.
For more information please contact info@blymum.com
RI-NOTIFICA INTEGRATORI ALIMENTARI 2
04/04/2022
In questi giorni, Il Ministero della Salute ha precisato che a partire dal 30 giugno 2022, oltre a non pubblicare più il Registro Integratori Alimentari, procederà altresì alla cancellazione dal Registro Nazionale Integratori Alimentari (RNIA) delle referenze precedentemente notificate in modalità cartacea o via PEC.
Per questo motivo, a partire dal 1° luglio 2022, compariranno nell’RNIA solamente gli integratori notificati attraverso il sistema NSIS.
Se i Vostri integratori necessitano di essere rivisti nei contenuti ed essere ri-notificati con la nuova modalità per conservare la presenza nel Registro Nazionale Integratori Alimentari, saremo lieti di assistervi.
Immagine per gentile concessione di Bru-nO su pixabay.com
Per questo motivo, a partire dal 1° luglio 2022, compariranno nell’RNIA solamente gli integratori notificati attraverso il sistema NSIS.
Se i Vostri integratori necessitano di essere rivisti nei contenuti ed essere ri-notificati con la nuova modalità per conservare la presenza nel Registro Nazionale Integratori Alimentari, saremo lieti di assistervi.
Immagine per gentile concessione di Bru-nO su pixabay.com
YOLO ECONOMY & WELLBEING
05/04/2022
The YOLO Economy is often associated with the pursuit of individual pleasure, at the expense of corporate fatigue and stress, lack of long-term commitments, professional changes without a vision of the future, and excessive risk appetite of those concerned.
If on the one hand we get an endless flow of creative ideas of Millennials (and not only), to achieve a better balance between personal and working life, on the other hand we perceive a certain concern for the future (first of all that of the company) and for the progressive reduction of responsibilities and long-term commitment by new generations.
But, to paraphrase Peter Drucker, opportunity always brings responsibility. Personal well-being is in the life cycle of each of us the result not only of our ingenuity of the moment, but also of the investment of those who preceded us, grew up and supported us at the start. The investment that must be re-generated: yes, You (We) Only Live Once, but not at the expense of others. It is a question of individual sustainability.
So welcome is this moment in which millions of people are re-evaluating their professional careers, their priorities and looking for a new purpose in life. But it must be managed both on a personal level and on a system level. It is a complex process, which requires a mix of particular skills, with the aim at being a manager of oneself, of one's happiness and also of one's sustainability. The pursuit of well-being is an act of awareness, responsibility, gratitude, and generosity.
In our LIVELLA® Self Wellbeing Management Program we also address these issues.
In case of interest, do not hesitate to contact us for further information.
If on the one hand we get an endless flow of creative ideas of Millennials (and not only), to achieve a better balance between personal and working life, on the other hand we perceive a certain concern for the future (first of all that of the company) and for the progressive reduction of responsibilities and long-term commitment by new generations.
But, to paraphrase Peter Drucker, opportunity always brings responsibility. Personal well-being is in the life cycle of each of us the result not only of our ingenuity of the moment, but also of the investment of those who preceded us, grew up and supported us at the start. The investment that must be re-generated: yes, You (We) Only Live Once, but not at the expense of others. It is a question of individual sustainability.
So welcome is this moment in which millions of people are re-evaluating their professional careers, their priorities and looking for a new purpose in life. But it must be managed both on a personal level and on a system level. It is a complex process, which requires a mix of particular skills, with the aim at being a manager of oneself, of one's happiness and also of one's sustainability. The pursuit of well-being is an act of awareness, responsibility, gratitude, and generosity.
In our LIVELLA® Self Wellbeing Management Program we also address these issues.
In case of interest, do not hesitate to contact us for further information.
Image courtesy of geralt at pixabay.com
RI-NOTIFICA INTEGRATORI ALIMENTARI
02/02/2022
A partire dal 30 giugno 2022, il Ministero della Salute non pubblicherà più il Registro degli Integratori Alimentari. Continuerà ad essere aggiornato il solo Registro Nazionale degli Integratori Alimentari.
In conseguenza di ciò, dal 1° luglio 2022, i prodotti presenti nel Registro degli Integratori Alimentari, notificati a partire dall’anno 2015 in cartaceo o tramite PEC, non potranno più essere posti in commercio, a meno che non siano ri-notificati entro il 30 giugno p.v. attraverso l’NSIS. Siamo a Vs completa disposizione per l’assistenza del caso.
In conseguenza di ciò, dal 1° luglio 2022, i prodotti presenti nel Registro degli Integratori Alimentari, notificati a partire dall’anno 2015 in cartaceo o tramite PEC, non potranno più essere posti in commercio, a meno che non siano ri-notificati entro il 30 giugno p.v. attraverso l’NSIS. Siamo a Vs completa disposizione per l’assistenza del caso.
RE-START 2022
14/01/2022
We can help You with innovation in 2022!
WORKPLACE WELLBEING
First of all, with the LIVELLA® Self Wellbeing Management project, dedicated to improving individual prosperity and comfort in the four spheres Body, Mind, Work and World, with tangible benefits both for Your people and for Your Company.
COLLABORATIVE INNOVATION
We support You within Collaborative Innovation processes, following ISO 56002 and 56003, through smart working on visual collaboration platforms (i.e., Mural, Miro), and personalized mentoring aimed at enhancing individual and group skills of Your human resources.
VALUE PROPOSITION MODELING
If you have to manage structural interventions of your business system, we also point out the BUSINESS MODEL based INNOVATION method (CINNAM BMI-ALDEHYDE MBS®) that greatly facilitates the management of changes at all levels, from strategic development of the company/brand to the formulation of frontline value propositions of commercial and technical offers for the market.
For all forms of collaboration, it is possible to interact in presence and/or remotely, always with a mindset of sustainability, wellbeing, smart working and creativity.
For more information and references contact: merlinova@blymum.com
Image courtesy of Gerd Altmann from Pixabay
WORKPLACE WELLBEING
First of all, with the LIVELLA® Self Wellbeing Management project, dedicated to improving individual prosperity and comfort in the four spheres Body, Mind, Work and World, with tangible benefits both for Your people and for Your Company.
COLLABORATIVE INNOVATION
We support You within Collaborative Innovation processes, following ISO 56002 and 56003, through smart working on visual collaboration platforms (i.e., Mural, Miro), and personalized mentoring aimed at enhancing individual and group skills of Your human resources.
VALUE PROPOSITION MODELING
If you have to manage structural interventions of your business system, we also point out the BUSINESS MODEL based INNOVATION method (CINNAM BMI-ALDEHYDE MBS®) that greatly facilitates the management of changes at all levels, from strategic development of the company/brand to the formulation of frontline value propositions of commercial and technical offers for the market.
For all forms of collaboration, it is possible to interact in presence and/or remotely, always with a mindset of sustainability, wellbeing, smart working and creativity.
For more information and references contact: merlinova@blymum.com
Image courtesy of Gerd Altmann from Pixabay
COVID AS A SAE IN CLINICAL INVESTIGATIONS
03/06/2021
SARS-CoV-2 aka Covid-19 is an untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) which is currently affecting some of the subjects enrolled in clinical studies. It is a Serious Adverse Event (SAE) that can lead to death or serious deterioration in the health of subjects, their families, or other persons.
We are currently monitoring a Randomized Double Blind Placebo Controlled Clinical Study to evaluate the efficacy of a specific Medical Device. Because of Covid-19 we have registered a statistically significant increase of drop-outs, dangerously approaching the threshold of subjects that we have set as the drop-out limit for the termination of the clinical investigation on statistical grounds.
The teaching is clear: during SARS-CoV-2 Pandemic, while defining the statistical design, the methods and the analytical procedures of a new clinical investigation, pay higher attention to the sample size, since it can be conditioned by further unpredictable occurrences. You will avoid additional enrollments, extra amendments to the CIP and preserve the robustness of the statistical results within previewed deadlines.
Image by Gerd Altmann from Pixabay
We are currently monitoring a Randomized Double Blind Placebo Controlled Clinical Study to evaluate the efficacy of a specific Medical Device. Because of Covid-19 we have registered a statistically significant increase of drop-outs, dangerously approaching the threshold of subjects that we have set as the drop-out limit for the termination of the clinical investigation on statistical grounds.
The teaching is clear: during SARS-CoV-2 Pandemic, while defining the statistical design, the methods and the analytical procedures of a new clinical investigation, pay higher attention to the sample size, since it can be conditioned by further unpredictable occurrences. You will avoid additional enrollments, extra amendments to the CIP and preserve the robustness of the statistical results within previewed deadlines.
Image by Gerd Altmann from Pixabay
Clinical Evidence Management
09/02/2021
Starting from May 2021, a significant change in legislation on medical devices (Regulation 2017/745) will reinforce the requirements for clinical evaluation and place more emphasis on a life-cycle approach to safety backed up by clinical data. Act now to be ready on time!
Our services pertaining to the MDR are proposed as BLYMUM Clinical Evidence Management (B-CEM). They are aimed at :
For more information:
Clinical Evidence Management
Image background: Gerd Altmann
Our services pertaining to the MDR are proposed as BLYMUM Clinical Evidence Management (B-CEM). They are aimed at :
- casting partners for clinical investigations, in order to ensure the collaboration with the most appropriate and internationally recognised scientists and experts from primary academic and research Institutions,
- ground-working, supporting You throughout the scientific documentation assessment, regulatory compliance, investigational site assessment, and risk management (ISO 14971),
- planning clinical investigations, monitoring activities, and post market clinical follow-up; composing, according to the MDR, instructions, the clinical investigation plan (CIP) monitoring plan (MP) and clinical follow-up plan CFP), and
- monitoring and reporting data according to the monitoring plan.
For more information:
Clinical Evidence Management
Image background: Gerd Altmann
SELF WELLBEING | body | mind | work | world
30/11/2020
Several researches, such as the one from Euromonitor International (https://go.euromonitor.com/white-paper-ch-2020-health-by-generation.html ) confirm the continuous and global increase in the fragility and discomfort of people. Being aware of the several individual difficulties and their impact on personal well-being, we decided to rethink the settings of our Livella® program dedicated to the management of Self-Wellbeing.
The Livella® philosophy and methodology, inspired by the physiological modulation theory (https://www.blymum.com/contents/files/PAPER-PH.MODULATORS-CORNELLI.pdf ), is currently focused on improving physical (BODY) and mental (MIND) health. However, work and social relationships, in difficult contexts as it is today for many, become truly crucial for existence and personal comfort and prosperity.
Consequently, from now on, Livella® Self-Wellbeing professional consulting and mentoring integrates also Self-Management, Self-Marketing and Self-Innovation tracks for the management of the working sphere and interpersonal relationships. Livella®, our approach to the balance management of the human being, will be defined by the proportions among BODY, MIND, WORK and WORLD dimensions, with tangible benefits for both people, companies and the market.
The Livella® philosophy and methodology, inspired by the physiological modulation theory (https://www.blymum.com/contents/files/PAPER-PH.MODULATORS-CORNELLI.pdf ), is currently focused on improving physical (BODY) and mental (MIND) health. However, work and social relationships, in difficult contexts as it is today for many, become truly crucial for existence and personal comfort and prosperity.
Consequently, from now on, Livella® Self-Wellbeing professional consulting and mentoring integrates also Self-Management, Self-Marketing and Self-Innovation tracks for the management of the working sphere and interpersonal relationships. Livella®, our approach to the balance management of the human being, will be defined by the proportions among BODY, MIND, WORK and WORLD dimensions, with tangible benefits for both people, companies and the market.
Image courtesy of Gerd Altmann from Pixabay
QUALITY STANDARDIZATION | SERVICE SUSTAINABILITY | PEOPLE WELLBEING
26/10/2020
Blymum supports explicitly the Sustainable Development Goals of the United Nations and we fully adhere to the 3rd SDG: Good Health and Wellness for People. We provide services to pharmaceutical, food, healthcare and other clients and, through our professional activities, we concretely contribute to people’s health, physical and psychological wellbeing, longevity and beauty.
All customers and consumers today ask for greater safety and more guarantees. For the sake of satisfying these specific requests and ensuring the correctness, sustainability and efficiency of our working processes, we observe in particular the following ISO Standards: ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects; ISO 22000 - Food Safety Management; ISO 45001 - Occupational Health and Safety; ISO 26000 - Social Responsibility, together with the ICH Good clinical practice E6(R2) and the WMA Declaration of Helsinki.
QUALITY STANDARDIZATION, SERVICE SUSTAINABILITY and PEOPLE WELLBEING is a challenging combination of our distinct value proposition on the market.
Image courtesy of fotographic1980 at FreeDigitalPhotos.net
All customers and consumers today ask for greater safety and more guarantees. For the sake of satisfying these specific requests and ensuring the correctness, sustainability and efficiency of our working processes, we observe in particular the following ISO Standards: ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects; ISO 22000 - Food Safety Management; ISO 45001 - Occupational Health and Safety; ISO 26000 - Social Responsibility, together with the ICH Good clinical practice E6(R2) and the WMA Declaration of Helsinki.
QUALITY STANDARDIZATION, SERVICE SUSTAINABILITY and PEOPLE WELLBEING is a challenging combination of our distinct value proposition on the market.
Image courtesy of fotographic1980 at FreeDigitalPhotos.net
CLINICAL TRIALS MANAGEMENT | Market Networking & Monitoring
01/10/2020
Our Clinical Trials Services pertaining to food supplements, functional & novel foods, nutraceuticals, cosmetics and medical devices are aimed at both identifying professional partners for Clinical Investigations and supervising the progress of their whole process.
Through our networking activity, we ensure the collaboration with specialized and internationally recognized Opinion Leader Scientists from primary Academic Institutions, with the advantage of enhancing and accelerating the CIP procedure, the survey site selection and the investigated subjects’ enrollment.
Through our monitoring activity, we verify that the conduct of Clinical Investigations complies with the approved CIP, its subsequent amendments, international standards and legislative requirements. Our professionals have experience, scientific knowledge and skills in the use of medical devices and the other above-mentioned categories of products, and are familiar with the relevant requirements and control systems.
The combination of these activities represents an efficient, effective and distinctive benefit for all companies interested in validating their offer on the market through Clinical Investigations based in Italy.
Image courtesy of renjith krishnan at FreeDigitalPhotos.net
Through our networking activity, we ensure the collaboration with specialized and internationally recognized Opinion Leader Scientists from primary Academic Institutions, with the advantage of enhancing and accelerating the CIP procedure, the survey site selection and the investigated subjects’ enrollment.
Through our monitoring activity, we verify that the conduct of Clinical Investigations complies with the approved CIP, its subsequent amendments, international standards and legislative requirements. Our professionals have experience, scientific knowledge and skills in the use of medical devices and the other above-mentioned categories of products, and are familiar with the relevant requirements and control systems.
The combination of these activities represents an efficient, effective and distinctive benefit for all companies interested in validating their offer on the market through Clinical Investigations based in Italy.
Image courtesy of renjith krishnan at FreeDigitalPhotos.net
#SDG 2 Treatment of Anaemia | Food Supplement RUBENFLUX®
06/07/2020
Inside the 2nd United Nations' SDG Goal: END HUNGER, ACHIEVE FOOD SECURITY AND IMPROVED
NUTRITION AND PROMOTE SUSTAINABLE AGRICULTURE, there is a particular Target 2.2, aimed at ending all forms of malnutrition, and addressing the nutritional needs of adolescent girls, pregnant and lactating women and older persons. Within the Global indicator framework for the Sustainable Development Goals and targets of the 2030 Agenda for Sustainable Development, a particular attention is given to a specific KPI “Prevalence of anaemia in women aged 15 to 49 years, by pregnancy status (percentage)”.
Our product RUBENFLUX® is a dietary supplement of essential amino acids, vitamin C, Group B vitamins and iron, for the female market, indicated for the red blood cells and hemoglobin natural formation and for the reduction of tiredness and fatigue. The RUBENFLUX® formulation, supported by clinical trials, scientific publications and granted with an IP by the Italian Patent office, is developed following the basis of Physiological Modulation.
RUBENFLUX® is proposed for on-demand production, international licensing and/or definitive purchase for those Companies strategically involved in the treatment of anaemia, directly or through commercial activities.
For further information/queries please contact: info@blymum.com
NUTRITION AND PROMOTE SUSTAINABLE AGRICULTURE, there is a particular Target 2.2, aimed at ending all forms of malnutrition, and addressing the nutritional needs of adolescent girls, pregnant and lactating women and older persons. Within the Global indicator framework for the Sustainable Development Goals and targets of the 2030 Agenda for Sustainable Development, a particular attention is given to a specific KPI “Prevalence of anaemia in women aged 15 to 49 years, by pregnancy status (percentage)”.
Our product RUBENFLUX® is a dietary supplement of essential amino acids, vitamin C, Group B vitamins and iron, for the female market, indicated for the red blood cells and hemoglobin natural formation and for the reduction of tiredness and fatigue. The RUBENFLUX® formulation, supported by clinical trials, scientific publications and granted with an IP by the Italian Patent office, is developed following the basis of Physiological Modulation.
RUBENFLUX® is proposed for on-demand production, international licensing and/or definitive purchase for those Companies strategically involved in the treatment of anaemia, directly or through commercial activities.
For further information/queries please contact: info@blymum.com
REGULATORY COMPLIANCE SERVICES | Smart Wellbeing Modulations
08/06/2020
Recently, we have drawn up and followed the submission, through an international recognized patent office, of a third party’s patent application pertaining to a Class III medical device to treat Obstructive Sleep Apnea (OSA). The patent application has successfully been published last July 2019 and is currently being finally approved and released by the European Patent Office (EPO) as an official intellectual property.
If new Clients wish us to assist them in studying, drafting and deposit new IPs, we will be proud to assist them with dossier filing, technical support, and regulatory compliance.
For more information contact: info@blymum.com
Image courtesy of Danilo Rizzuti at FreeDigitalPhotos.net
If new Clients wish us to assist them in studying, drafting and deposit new IPs, we will be proud to assist them with dossier filing, technical support, and regulatory compliance.
For more information contact: info@blymum.com
Image courtesy of Danilo Rizzuti at FreeDigitalPhotos.net
CLINICAL TRIALS MANAGEMENT | Class III Medical Device
06/05/2020
In the past 20 Years the members of our Team have developed a substantial clinical experience with slimming products (food supplements and medical devices) which is constantly at Your disposal for future investigations.
This May 2020 Blymum has started a new clinical trial management together with both the University of Pavia and the University of Milan. A 3-month randomized double blind placebo-controlled investigation with 120 subjects has been successfully designed and implemented. The aim of the study is to assess the ability of a German made class III Medical Device, marketed in 47 countries Worldwide, to reduce/manage weight. The enrollment is currently underway.
We carry out Clinical Trials Design & Project Management activities, throughout all key phases: Experimental Design; Dossier Set-up; Participant Enrollment; Treatment & Monitoring Support; Clinical Data Management.
Our distinctive Clinical Trials Management timeframe can be easily applied to any Class III Medical Device.
For more information contact: info@blymum.com
This May 2020 Blymum has started a new clinical trial management together with both the University of Pavia and the University of Milan. A 3-month randomized double blind placebo-controlled investigation with 120 subjects has been successfully designed and implemented. The aim of the study is to assess the ability of a German made class III Medical Device, marketed in 47 countries Worldwide, to reduce/manage weight. The enrollment is currently underway.
We carry out Clinical Trials Design & Project Management activities, throughout all key phases: Experimental Design; Dossier Set-up; Participant Enrollment; Treatment & Monitoring Support; Clinical Data Management.
Our distinctive Clinical Trials Management timeframe can be easily applied to any Class III Medical Device.
For more information contact: info@blymum.com