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Dr. Milen Vrabevski awarded the honorable certificate “The doctors we trust”

The owner and CEO of Comac Medical Dr. Milen Vrabevski was awarded an honorable certificate by the prestigious medical edition “The doctors we trust”, which once again brought together the most authoritative and respected physicians and managers of medical institutions in Bulgaria.

“I want to thank all the doctors. The importance of the medical profession was recognized by the society. There is more positive attitude towards Bulgaria now and in hard times people remember the state that can lend them a hand,” said during the event Dr. Milen Vrabevski.

“Instead of being judges of the state, we should at certain moments replace it and make sure that Bulgaria is acknowledged,” he recommended. “Bulgarians from abroad should be in the focus of our attention and as a civilized European country we should think about them. In this regard I am crossing the borders of Bulgaria and in addition to my personal example, I made several key donations to the Republic of Northern Macedonia for the colleagues fighting the Coronavirus pandemic from the first line ensuring the most necessary protective equipment is available – these are the cities St. Nicholas, Delchevo and Strumica. Then I moved on to Albania, Prespa region, where I bought an ambulance, a car for social care and a fire truck, “said Dr. Vrabevski.

This year the ceremony held a minute’s silence in memory of the doctors who lost their lives in the fight against Covid-19. Due to the pandemic, the event was held in a different format, and thousands of people watched the online discussion of experts on the topic “The day after tomorrow”.

We would like to remind you that Dr. Vrabevski was included in the prestigious medical edition:” The doctors we trust”, issued yearly in Bulgaria. A total number of 600 Bulgarian doctors, medical centers and hospitals were included as nominees. Nominations were done directly by the patients based on certain criteria like health care, competence, empathy.

On 09 November, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. The issuance of an EUA is different from FDA approval. In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. As part of the evaluation of the EUA, the agency imposed several quality measures to protect patients. The company owning the proprietary rights is required to implement these quality measures to manufacture this drug under the EUA.

Bamlanivimab is authorized for patients with positive results from direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.

While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

Based on its review of the scientific evidence available, the FDA determined that it is reasonable to believe that bamlanivimab may be effective in treating non-hospitalized patients with mild or moderate COVID-19.

You can access the whole article here

Stay safe!

More than 250 professionals from 40 pharmaceutical companies took part in the Pharma NextGen conference – an event organized and held on October 22 by CredoWeb. The setup of the event was digital, through pre-recorded video presentations, interviews, and expert opinions. 20 presenters shared their experience in the use of new generation digital and technological solutions, marketing tools, and business models in the pharmaceutical industry.

After each of the panels of the event, discussions were held. The key topics were related to online communication with medical professionals, the importance of content for each project, team-integration in the company, the relationship between digital activities and sales, and many other trends in the “new normal”.

The marketing teams of several generic companies held presentations covering different areas in terms of tools, goals, and achieved results. This was also the focus of the presentation delivered by our dear colleague, Dariya Raykova – PR specialist at Comac Medical. She presented modern approaches to the targeted recruitment of volunteers in clinical trials and showcased how Comac Medical has upgraded traditional digital channels to reach potential participants in clinical trials related to the treatment of Diabetic Foot Ulcer (DFU) and Atopic Dermatitis.

The PR specialist pointed out that digital marketing allows to recruit potential volunteers faster, but stressed that from that moment forward, the contact is “transferred” from online to an offline environment, where an expert in the disease field contacts the candidates, responds personally to all subsequent questions, and then makes the final selection. The key to success is in the precise balance between online and offline activities, the good team collaboration, and the participation of field experts.

After successfully passing a pre-approval FDA inspection, Comac Medical’s Clinical Research Unit has been honored with a NAI certificate.

The scheduled US FDA visit lasted 5 days – between 10th and 14th of February 2020. During the inspection, the Clinical Research Unit was checked for compliance with the US FDA requirements. The inspection included extensive review of documentation, and no FDA Form 483 has been issued.

After the inspection, the FDA determined that the areas evaluated are in compliance with applicable laws and regulations. The FDA and the Inspection Classification Database classified the inspection with NAI, which means no objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action).

“Thank you all for doing a fantastic job!”, commented the Vice-President of the Sponsor of the inspected study, congratulating the whole Comac Medical team.

The blinded NAI Letter can be obtained from the  Certifications page  on the Comac Medical website.

 

The owner and CEO of Comac Medical dr. Vrabevski was included in the prestigious medical edition:” The doctors we trust”, issued yearly in Bulgaria. A total number of 600 Bulgarian doctors, medical centers and hospitals have been included as nominees. Nominations are done directly by the patients based on certain criteria like health care, competence, empathy. Dr. Vrabevski accepted the recognition. “Modern medicine is impossible without innovation, so Comac Medical is constantly applying innovative practices. The investment in innovative products is an integral part of the company’s growth”, commented dr. Vrabevski on the nomination.

“The doctors we trust” bring together the most authoritative and respected medics in Bulgaria.

There will be official ceremony and event. Stay tuned on more news 🙂

The U.S. Food and Drug Administration added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” This guidance is intended for industry, investigators and institutional review boards.

Updates May 12, 2020: The updated guidance includes new content with considerations for using alternate laboratories or imaging centers, holding trial participant visits via video conference, and conducting required postmarketing clinical trials. The guidance also includes updated information about managing protocol deviations and amendments to ongoing trials, and about consulting with FDA regarding administering investigational product infusions at home rather than at the clinical trial site.

Updates June 3, 2020: The updated guidance has a new question-and-answer on Part 11 compliance for electronic systems that are used to generate electronic signatures on clinical trial records. The guidance cites the COVID MyStudies App as an example of an electronic method for obtaining informed consent securely when face-to-face contact is not possible. In addition, the guidance further expands on an existing question-and-answer about remote clinical outcomes assessments (COAs) to include four types of COAs: performance outcomes, interview-based clinician-reported outcomes, patient-reported outcomes, and observer-reported outcomes.

Updates July 6, 2020: The updated guidance clarifies two previously suggested methods for obtaining informed consent from a hospitalized patient in isolation. In addition, the guidance includes a new question-and-answer regarding how to obtain informed consent from a prospective trial participant in certain circumstances where the enrollment timeframe is limited and the patient can receive a copy of an informed consent document electronically but cannot sign it electronically or print it out for signature. The guidance also clarifies recommendations on documenting details when using video conferencing for trial visits.

You can access the guidance in English here

The owner and CEO of Comac Medical, Milen Vrabevski, MD received recognition for his social projects and investments in Bulgaria and the Balkan region. Dr. Milen Vrabevski was awarded in the category “Humanism and impact investing” as part of the National Medical Awards 2020 competition.

The award is given to a public person who has made an outstanding contribution to public life, consistent with humanistic principles and values. The awarded person must have displayed a reasoned and compassionate approach to community well-being and be a well-known public figure whose social projects lead to measurable social impact and improved human lives.

Dr. Milen Vrabevski ventures in funding numerous initiatives related to healthcare, scientific research, education, reintegration of the Bulgarian diaspora, and the support of young talents in Bulgaria, all of which were taken into consideration when shortlisting the award nominees. Full details here

Many prominent names in the industry were recognized at the official event ceremony which took place on June 25, 2020 at the ballroom of Marinela Hotel in Sofia.

Partners of the event are the National Patient Organization (NGO), the Bulgarian Medical Association (BMA), and the National Association of General Practitioners (NAGP), the Sofia Medical College at the BMA and others.

Comac Medical’s “Take a responsible step” diabetic foot ulcer (DFU) awareness campaign was honored with a National Medical Award for the category „Social Responsibility and human resources in the medicine“.

Comac Medical, established 23 years ago, celebrated its recognition for demonstrated expertise, care, and sense of community in the area of DFU disease prevention.

The campaign was targeted at patients with DFU in Bulgaria. It was developed to create awareness for the complications of the disease and to work on a prevention program to make patients conscious of their disease stage and next steps in the treatments process.

Launched in 2019 in partnership with 4 medical centers and more than 10 physicians, including surgeons and endocrinologists, this award-winning campaign pioneered a new approach to raise awareness across the nation about DFU.  The undertaken approach included the following elements:

  • Creating awareness among patients through articles from physicians published in national media about risks of amputation, informing people that these risks can be dramatically reduced, and prompting them to ask for more information.
  • Initiating а “free-consultations” program offering clinician support and advice to patients about the associated risks of complications, amputation, risk-reduction choices, and available treatments.
  • Participating in local and national events to consult patients about their condition with a focus on giving patients context and choice about which risks they want to tackle, when and how.
  • Developing a patient information leaflet for people with diabetes and foot ulcers which can be used alongside existing information resources.

Commenting on the awards, Dariya Raykova, PR of the campaign, said: “I am very proud and happy that we won the award. As a company that provides healthcare services, our aim is improving people’s quality of life. Therefore, we have to constantly work on raising social awareness of diseases.”

The award was given at an official ceremony on June 25, 2020.

Partners of the event are the National Patient Organization (NGO), the Bulgarian Medical Association (BMA), and the National Association of General Practitioners, the Sofia Medical College at the BMA and others.

The owner and CEO of Comac Medical, Milen Vrabevski, MD, continues to receive recognitions for his philanthropic projects and investments in Bulgaria and the Balkan region. Milen Vrabevski, MD, has been nominated in the category “Humanism and impact investing” in the National Medical Awards 2020 competition. The nomination emphasizes the importance of humanistic and philanthropic projects among industry experts.

Some of the biggest ventures championed by our CEO in 2019 are taken into consideration for the nomination:

-The unprecedented commitment to accelerate the development of a new vaccine for COVID-19 which resulted in Comac Medical launching a partnership with a global pharmaceutical company

-The investments in projects supporting the development of the Balkan region, the Bulgarian diaspora in the Balkans, Ukraine and Moldova through the activities of the Bulgarian Memory Foundation (BGMF) as mentioned below:

    • Donations of protective equipment to the Republic of North Macedonia amid the global coronavirus pandemic (article here)
    • The infrastructure improvements in the local water supply system in Prespa (Albania), funded by Milen Vrabevski, MD, ensuring 24/7 water supply in 2 out of 9 villages in the region
    • The purchase of a fire truck, an ambulance and a car which are also delivered to the people living in Prespa. They will serve 10,000 people in areas where people live in extreme poverty and completely isolated from the world due to the devastating earthquake that struck Albania recently.

– “Big Family” initiative that continues to support 15 low income families with more than 3 children around Bulgaria.

– The continued investment in the Bulgarian education through the activities of the owned by Milen Vravevski, MD, private school Tsar Simeon Veliki in Sofia, which impressive construction and modern facilities mirror his vision for modern European education.

Some of the most prominent names of the industry will be recognized at the event. The ceremony will take place on June 25 at the ballroom of Marinela Hotel, Sofia.

Partners of the event are the National Patient Organization (NGO), the Bulgarian Medical Association (BMA) and the National Association of General Practitioners (NAGP), the Sofia Medical College at the BMA and others.

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic: MyStudies app is now available to investigators as a free platform to obtain informed consent securely from patients for eligible clinical trials.

Through the COVID MyStudies app, the investigator can send the informed consent document electronically to the patient or his or her legally authorized representative. Once the patient or representative has signed the form, he or she will receive an electronic copy. The investigator can then access the signed consent in a secure manner and print it or transfer the file electronically.

More info here

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