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Father and son, Paolo and Giovanni Camici talk to CardioPulse about what brings them together and what sets them apart Paolo Camici MD is Professor of Cardiology at the how to order viagra Vita-Salute University San Raffaele in Milan, Italy. He previously held several senior roles in a long association with Hammersmith Hospital and Imperial College, London, UK.‘I was born in Genoa, a port in the north west of Italy and perhaps because of this I have always been attached to the sea and enjoyed water sports. My father was an ophthalmologist, my uncle was an internist, and my grandfather was how to order viagra a general practitioner.

Whenever the family got together around the table for Sunday lunch, they would always be talking about medicine, so its in my blood.When I was around four or five, my father was keen to go back to his native Tuscany, so we moved to Pisa and I completed my education in a liceo classico. When it came to university, it seemed as how to order viagra natural as breathing to go into medicine and I enrolled at medical school in Pisa. After gaining my medical degree I was not sure what I wanted to do.

Psychiatry was popular at that time, but after a 6-month internship, I decided I did not want to be a psychiatrist. I was quite interested in research and physiology and I got an interview with Luigi Donato, a well-known professor for a position at the new Institute of Clinical Physiology at the University of Pisa how to order viagra. I was offered a job and assigned to Attilio Maseri who suggested I work with cardiologist Antonio L’Abbate.

It was here that I spent several years while doing my internship in cardiology and internal medicine.In the late 1960s, I first visited London as a tourist which was a big thing for me as the city was the centre of everything at that time and I was a huge fan of how to order viagra rock music and sang in a band. I later returned to the city in 1977 to train in clinical pharmacology, then in 1980 Maseri announced that he was leaving Pisa for London and a professorship at Hammersmith Hospital. This was a big blow to me as he was a big influence, so the following year, I began to commute between London and Pisa to carry out research.

I got to know physicist Terry Jones who oversaw the cyclotron unit at Hammersmith Hospital and in 1990 he called me to say they were opening a new group for PET in cardiology and needed how to order viagra a young leader ready to come to London. It took about 10 s to say yes, and I took leave from my assistant professorship at Pisa and moved to London where I eventually received a Medical Research Council (MRC) tenure and was appointed to a professorship at Imperial College. Giovanni was born in Pisa in 1976 and moved to the UK how to order viagra when he was 13.

He attended the European School in Culham, Oxford where he did the European Baccalaureate before studying for a Biology BSc at Queen Mary University of London. After he graduated, he worked in London for a bit and was later accepted as a member of Tom Lüscher’s group at the University of Zurich in Switzerland. That was 17 years ago and how to order viagra during that time Giovanni completed a PhD in Fribourg and became Director of the Center for Molecular Cardiology.

Although I discussed career options when Giovanni was looking to specialize in biological sciences, I wanted him to make his own decisions. I did not want him to be influenced by me in the how to order viagra way I was influenced by my own family or in the way that some children are influenced by parents who think they know what is best for their child. Although our work roles are different, there are some similarities, but I think what we have in common is our attitude towards working life in that the human aspect is very important for us.

We both find it easy to communicate and get on well with people and although we love our work and enjoy teaching and research, we are not obsessed with it and we make time for other things such as hobbies, family, and friends.I do not think that his career was necessarily easier than mine because I feel there were more options for me, and the field was not as competitive as it is today. We have never looked for the opportunity to work together, but of course we talk about how to order viagra science and our work and exchange ideas. One of the main differences I see with my son’s life in comparison to mine is that he is a much better father than I was, in that he devotes much more time to his family than I did.

We are good friends as father and son and have how to order viagra many hobbies in common such as vintage cars and music. And together with my daughter Valeria, Giovanni’s sister, who chose a career as a music teacher and a singer, we get along very well and enjoy each other’s company.Giovanni Camici PhD spent his early years in Italy and later attended school and university in England. He is the Director of the Center for Molecular Cardiology at the University of Zurich which was set up in 2015 to focus on different aspects of cardiovascular research, including vascular ageing and stroke.

€˜When I was growing how to order viagra up, I thought the work that my father and relatives did was fascinating. I was always attracted by academia in general and although it is very different now, I still enjoy it and find it as fascinating as when I was a child. By the time I moved to England in 1990, I had already been exposed to the world of how to order viagra science and biology because of my father’s work as a clinician-scientist.

You could say I had the concept of science running through my veins from previous generations. Thanks to an inspiring biology teacher at school, I began to enjoy science for the first time on my own account and that continued, although I was not so good at subjects such as chemistry. At college in London, I how to order viagra was initially interested in neuroscience and general physiology.

However, when I finished university, I did a work placement for 18 months in a muscular dystrophy laboratory at Imperial College and I began to have doubts whether neuroscience was for me. My intention was to return to Italy, but after I got an offer to work in the research group of Thomas Lüscher, that was it.When I look back over the last 17 years in Zurich, I believe I have made considerable progress according to how to order viagra the usual parameters of success. However, the most important goal in life is to be happy with what I do, and I am flattered to be paid to use my brain to produce knowledge.

One of the things I am most proud of, is having set up the new laboratory in 2015. Before this, how to order viagra we were based on a different campus and although it took me a year’s work, I am proud of that and of having become the Director. Molecular cardiology is a discipline which is of great relevance to humanity.

Although we have made major advances, cardiovascular diseases are still the main cause of death worldwide and this means there is still a huge need for progress in the field and this is how to order viagra a strong motivation for me. I have a very special relationship with my father in the sense that we have tended to go our own way as far as work is concerned. However, this has changed quite a lot since I became a professor, so over the last how to order viagra 3 or 4 years, we have developed a much closer relationship professionally.

In the past, he wanted me to choose my own way, although he was always there for important things. I think he also wanted to avoid using his high profile and professional reputation to influence my career too much. Now I consult him and ask for advice much more often, how to order viagra although my reference professionally remains Professor Lüscher.Its difficult to compare my career path with that of my father, but one thing I am aware of is how much society is now largely governed by interests that concern money and this means there isn’t much space for the academic environment.

Universities are non-profit organizations so there is less funding for them and less opportunity to work in them. Its OK how to order viagra in the early stages of your career, but there is a pyramid structure with very few positions available and as soon as you have a PhD it really is a huge struggle to get on.You also need to be a very complete and well-rounded person to be able to do well in science. I do not know of any other jobs where you have to decide what to do, find the money to do it, carry out the project and sell it.

Then if it does not work, you are out. In comparison my father gained a permanent academic position in his mid-30s and had opportunities and security which would be how to order viagra impossible for my generation. We certainly have more technological means compared to the past, but things are much more complex than they were two or three decades ago.

If I was asked for advice, I would probably recommend the career of a physician over that of how to order viagra a researcher because you can be a physician at many different levels and in different situations and you can choose whether to do research or not. For a full-time scientist however, the struggle is a bit too harsh and I cannot see it getting better in the future unless people start to understand that investing in science is important. The reality is that you must raise funds to do science, to collect data and to publish.

It really is publish or perish, its a vicious circle.Although I do not think it was always easy for my father to keep his distance and not to come and lend a hand at times in my career, I cannot imagine that if I had grown up next to him that I would have become the person I am, maybe I would have sweated a how to order viagra bit less, but I do not think I would have become as confident or as well-developed. Although I did not always understand it at the time, I am thankful to my father for this now and I can appreciate what he did for me’. Conflict of interest how to order viagra.

None declared. Published on behalf of the European Society of Cardiology. All rights how to order viagra reserved.

© The Author(s) 2019. For permissions, how to order viagra please email. Journals.permissions@oup.com.LVTS is the present avatar of a long standing and highly productive multidisciplinary cardiovascular French institute created in 2005 by Dr Jean-Baptiste Michel and Dr Martine Jandrot-Perrus and headed since 2014 by Dr Didier Letourneur (Director) and Dr Antonino Nicoletti (Deputy Director).

Https://lvts.fr/ With 150 tenured researchers and engineers and around 60 post-docs, Master and PhD students (Figure 1), Laboratory for Vascular Translational Science (LVTS) is affiliated with Inserm and CNRS, the Paris University and University Paris 13 and the Greater Paris University Hospitals (AP-HP). Figure 1Members of LVTS.Figure 1Members of LVTS.The Institute is located north of Paris on the Bichat how to order viagra campus that harbours a 900-bed university hospital, a medical school, and a research hub. This location has fostered long-lasting and highly dynamic interactions between the institute and the hospital.

These have led to numerous common research projects and the establishment of a cardiovascular (CV) biobank from the collection of a large range how to order viagra of human samples (blood, tissue, and cells) from different forms of CV diseases, including atherothrombotic and non-atherothrombotic diseases (notably thoracic and abdominal aortic aneurysms, carotid artery diseases). The CV biobanking activities are integrated in the national Biobank network (Biobank Infrastructure), which are partners of EU BBMRI (www.bbmri.eu).LVTS has a pluri- and transdisciplinary approach with the objective to fight vascular pathologies. The medical questions raised pertain to new pathophysiological targets, in order to advance diagnosis and treatment of diseases.

The general objectives are the understanding of the physiological mechanisms by basic science approaches but also through how to order viagra large clinical trials, development of new diagnostic (markers and imaging), and new therapeutic/biomaterial strategies. Identification of new targets, development of new molecules, validated by clinical trials. To carry out how to order viagra these projects, translational human and technological skills include clinical databases and assays, translational clinical investigations (carotid stenosis, aneurysms, and dissections of the ascending aorta, Biocore), human tissue and cell biobanks, numerous experimental models of disease (transgenic mice, rats, rabbits), new methods in molecular and cell biology (genetics and genomics, proteomics, protein engineering, flow cytometry), chemistry of biopolymers, elaboration of biomaterials and nano systems, and imaging technologies in small animals and in humans [nuclear imaging, ultrasound, and magnetic resonance imaging (MRI)].Research is performed through six teams (Figure 2).

Their current research topics are briefly presented in the following paragraphs. Figure 2LVTS teams, their leaders, and their research areas.Figure 2LVTS teams, their leaders, and their research areas. Team 1The Cardiovascular Immunobiology team (Team how to order viagra 1, G.

Caligiuri and A. Nicoletti, Refs1–5) works on the mechanisms by which the immune system interacts how to order viagra with diseased vessels and designs new vasculoprotective immune interventions. The main recent contributions from this team have been.

The decryption of local immune how to order viagra responses around atherothrombotic vessels and description of new pathogenic immune pathways in vascular diseases. We have shown that recruited neutrophils can dictate the issue of complicated atheroma and that their activity is enhanced at sites of plaque erosion and also by infectious agents that harbour tropism for atherothrombotic sites. We are currently trying to dampen the myeloid cell-driven vascular damage in the brain, the heart, the lungs, and the intestine, upon ischaemia–reperfusion.

We are investigating the mechanisms through which periodontal diseases can deflect the innate immune response how to order viagra thereby impacting on the issue of atherothrombotic events.The demonstration that CD31 is a pacification molecule of the blood vessel interface thereby showing that it is a promising molecular target in inflammatory and thrombotic diseases. We have filed seven patents, six licensed to Tridek-One Therapeutics, a spin-off of our laboratory that aims at developing first-in-class immunomodulatory products targeting the CD31 pathway to down-modulate inappropriate immune responses.The revision of the processes initiating atherogenesis and vascular/valvular calcifications where we have shown that endothelial breaches in territories subjected to high haemodynamic stress allow the entry of red blood cells and constitute a key pathogenic mechanism underlying atherogenesis. In addition to mechanical stress, we are exploring the role of temperature, a neglected feature of how to order viagra inflammation.

We have found that temperature is different at sites of atherogenesis and can profoundly impact vascular and immune cell biology. Team 2The Vascular structural diseases team (Team 2, G. Jondeau and C how to order viagra.

Boileau, Refs6–11) focuses on the study of pathophysiogenic mechanisms associated with aortic aneurysms, valves and coronary artery disease (CAD) in an uninterrupted continuum from genetics to pathophysiology and patient care. The team focuses on inherited human how to order viagra model diseases. Thoracic aortic aneurysms (TAAD) in Marfan’s syndrome and associated diseases and autosomal dominant hypercholesterolaemia.

These models also provide means to identify the genetic modifiers that account for great clinical variability, between and within families. The identification of these modifiers should enable identification of predictors how to order viagra of disease aggressiveness. Research relies on a close collaboration with the National reference Center for Marfan syndrome (www.marfan.fr) and is part of the national large-scale translational research project CHOPIN (CHolesterol Personalized Innovation, https://rhuchopin.fr/).

In TAAD, we developed the how to order viagra paradigm shift that TGF-β canonical pathway has a protective effect during aneurysm formation. We are leaders in the discovery of new disease genes involved in familial TAAD. By cross-mapping the results of several genome-wide studies, we detected the existence and mapped 9 modifier loci that are being investigated.In familial hypercholesterolaemia (FH), we postulated further genetic heterogeneity and demonstrated the role of rare GOF mutations in the PCSK9 gene.

Our work identified a totally unrecognized actor of cholesterol homeostasis and opened up a new field of basic research and the development how to order viagra of anti-PCSK9 agents. Another paradigm shift showed that mutations in the APOE gene resulted in FH, as well as the existence of other FH disease genes. Team 3The Cardiovascular Bio-Engineering team (Team 3, how to order viagra D.

Letourneur, Refs12–18) is well-integrated in LVTS research, industrial development, clinical translation, and education. The team has a long-standing expertise in biomaterials and nanotechnologies and is developing research in e-health objects.Biomaterials—3D porous scaffolds for tissue engineering Innovative technology enables the development of different polysaccharide scaffolds for bone regeneration, skin regeneration, three-dimensional cell culture, and cellular or molecular delivery. Thanks to how to order viagra multiphysic and multiscale characterizations, our goal is to develop biomaterials for tissue regeneration in vivo.

Based on four patents, a company (SILTISS) was created for industrial transfer and is expected to launch clinical trials in 2021.Nanotechnologies for imaging and therapy We have developed a GMP fucoidan and several nanosystems for the early diagnosis of CV diseases with clinical imaging and the establishment of appropriate therapeutic strategies. Fucoidans are marine sulfated polysaccharides and previous studies have demonstrated the how to order viagra capacity of fucoidan to bind to P-selectin as a relevant marker of atherothrombosis and endothelial ischaemia. A GMP microdose radiopharmaceutical based on 99mTc-fucoidan has been validated in Phase I and Phase II clinical trials for single-photon emission computed tomography (SPECT) imaging of human thrombosis and heart ischaemia (FP7-NMP-Large-6-‘Nanoathero’).

We focus on three major areas. The development of soft nanosystems of which the core materials how to order viagra are polysaccharides. These are used as contrast agents for molecular imaging of CV disease by computed tomography (CT), MRI, SPECT, positron emission tomography (PET), ultrasonography, optical imaging, or some combination of these modalities.The development of ligands able to aim nanoparticles at molecular relevant targets, such as fucoidan for P-selectin.The development of therapeutic strategies by optimizing loading capacities and physicochemical properties well adapted to antioxidative molecules.

Team 4The Cardiovascular imaging team (Team how to order viagra 4, F. Rouzet, Refs19–23) aims at developing imaging agents and procedures from preclinical proof of concept to clinical validation. The preclinical imaging platform gathers all the modalities dedicated to small animals (ultrasounds, MRI, PET/MRI, SPECT/CT, and a radiolabelling lab) and is a member of the French Life Imaging network.

Our team has developed expertise in radiolabelling probes, nanoparticles, or cells with gamma and positron emitters (Gallium-68 and Copper-64) and more how to order viagra recently in multiparametric magnetic resonance (MR). Our research is fuelled by a strong interaction with other teams of LVTS for the development of novel imaging agents and takes advantage of the wide range of fully characterized animal models available onsite for in vivo validation (Figure 3). Figure 3Radiolabelled Fucoidan SPECT/CT in a rat model how to order viagra of myocardial ischaemia–reperfusion.

Fucoidan is a P-selectin-targeted imaging agent designed to identify the biological imprint of a transient ischaemic episode a few hours after its resolution. A focal uptake of the imaging agent is detectable at the left ventricular apex (green arrow) 2 h after how to order viagra reperfusion (left panel). Immunostaining demonstrates the endothelial expression of P-selectin (green fluorescence) at the endothelial surface (lectin) in the area at risk (right panel).Figure 3Radiolabelled Fucoidan SPECT/CT in a rat model of myocardial ischaemia–reperfusion.

Fucoidan is a P-selectin-targeted imaging agent designed to identify the biological imprint of a transient ischaemic episode a few hours after its resolution. A focal uptake of the imaging agent is detectable at the left ventricular apex (green arrow) 2 h how to order viagra after reperfusion (left panel). Immunostaining demonstrates the endothelial expression of P-selectin (green fluorescence) at the endothelial surface (lectin) in the area at risk (right panel).The clinical research including preliminary studies in humans takes place at Bichat hospital.

The proximity between LVTS and the hospital how to order viagra facilitates the interplay between clinical challenges and fundamental research. The main research topics of the team are centred on, biological activities associated with arterial thrombi such as pro-coagulant activity and serine proteases,tracking or detection of cells involved in inflammation/, andthree tissue biomechanical properties obtained from MR elastography.We are currently developing a multimodal approach combining the molecular information derived from PET, tissue contrast from MRI, and viscoelastic properties from MR elastography. This comprehensive characterization is developed in animal models of myocardial inflammation and fibrosis and will be translated to humans with the installation of a clinical PET/MR system by the end of 2020.

Team 5The atherothrombotic disease in heart how to order viagra and brain team (Team 5, P.G. Steg, Refs24–30) focuses on clinical epidemiology of CAD (P. Gabriel Steg) and how to order viagra stroke (P.

Amarenco), via the design, conduct and analysis of large-scale observational registries and of randomized clinical trials. The team recently received French government funding for an integrated research programme on innovations in atherothrombosis science (RHU IVASC, www.ivasc.eu) which involves ongoing epidemiologic studies and interventional studies to establish the relationship(s) between chronic periodontitis, sleep disordered breathing, and atherothrombosis. The TIA.org registry established the benefit of rapid management of transient ischaemic attacks through specialized centres worldwide, initially and at 5-year follow-up.Recent trials have studied the impact of lipid lowering interventions after acute coronary syndromes (using alirocumab, a PCSK9 inhibitor, in the ODYSSEY OUTCOMES trial) or after ischaemic stroke in patients with atherothrombosis (comparing two target LDL cholesterol levels, in the TST trial which established how to order viagra the clinical benefit of targeting LDL to <70 mg/dL rather than 100 mg/dL).

A large-scale trial, THEMIS (the largest randomized trial in diabetes) established the value of dual antiplatelet therapy with ticagrelor and aspirin in patients with stable CAD and diabetes, particularly if they have a prior history of percutaneous coronary intervention. Team 6The Haemostasis, how to order viagra Thrombo-Inflammation, Neurovascular Repair team (Team 6, M.C. Bouton and N.

Kubis, Refs31–35) focuses its research on the interaction between actors of haemostasis and thrombo-inflammation in the vessel wall to extend knowledge on cardio- and neurovascular diseases. The main themes of how to order viagra the team are. Heart failure.

Increased protease activities within the myocardium is how to order viagra involved in the development of heart failure. We have previously demonstrated that protease nexin-1, a major tissue antiprotease, constitutes a key factor in the responses of vessels to injury, via its antithrombotic and antifibrinolytic properties. We now aim to determine its potential role in cardiac pathophysiology.Intracranial aneurysm.

The pathophysiology evolution of intracranial aneurysm events how to order viagra seems driven by complex cellular interactions between different cell types including platelets, leucocytes, and vascular cells. Our main objective is to decipher platelet mechanisms during intracranial aneurysm formation and rupture.Stroke. We investigate how cellular actors of inflammation and molecular actors of haemostasis contribute to the pathophysiology of ischaemic stroke how to order viagra.

Our approach combines the analysis of thrombi and plasma samples recovered from stroke patients (Figure 4), and the use of animal models. We showed that thrombi from patients have thrombolysis- resistant areas,large vessel occlusion triggers downstream micro thrombosis, andDNAse can help improve thrombolysis. Figure 4Thrombus retrieved by mechanical thrombectomy from patients with ischaemic stroke how to order viagra.

Platelets (green) and neutrophils (red) immunostaining.Figure 4Thrombus retrieved by mechanical thrombectomy from patients with ischaemic stroke. Platelets (green) and neutrophils (red) immunostaining.Our work has set the basis for the development of clinical trials developing a personalized stroke care in emergency situations (BOOSTER consortium) and testing the efficacy of new drugs such as a novel anti-platelet drug (Phase Ib/IIa clinical trial ACTIMIS, Acticor Biotech, a spin-off company how to order viagra located in LVTS and created by Dr Martine Jandrot-Perrus, https://acticor-biotech.com/). ReferencesReferences are available as supplementary material at European Heart Journal online.Conflict of interest.

None declared. Published on behalf of the European how to order viagra Society of Cardiology. All rights reserved.

© The Author(s) 2020. For permissions, please email. Journals.permissions@oup.com..

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Health Product Inspection Database 2018-11-07 36 Inclusion of API in Australia-Canada Mutual Recognition Agreement 2018-11-01 35 Pause-the-clock proposal for drug and medical device establishment licence applications 2018-10-18 34 Introducing new blog 2018-10-15 33 Important reminders – Hurricane Florence 2018-09-27 32 Health Minister announces access to a U.S.-approved epinephrine auto-injector 2018-09-04 31 Stakeholder engagement seminars (GUI-0001) 2018-09-04 30 Notice of publication – GUI-0071 2018-07-10 29 Notice of consultation – GUI-0071 2018-07-05 28 Licensing requirements for reclassified high-level disinfectants and sterilants as medical devices 2018-07-23 27 Webinar GUI-0001 2018-06-01 26 Revised fee proposal for drugs and medical devices 2018-05-25 25 Important notice to stakeholders regarding revisions of drug establishment licensing guidance documents and forms as a result of amendments to the Food and Drug Regulations 2018-05-22 24 Antimicrobial regulatory amendment webinars affecting veterinary drugs what does viagra do – Drug establishment licensing and good manufacturing practices requirements 2018-03-29 23 GUI-0031 webinar 2018-03-15 22 Notice of publication 2018-02-18 21 Antimicrobial regulator amendment webinars affecting veterinary drugs – Health Canada 2018-02-07 20 GUI-0080 2018-01-09 19 Notice of consultation 2017-12-22 18 Pilot for sunscreen products 2017-12-21 17 Implementation of establishment licensing requirements for atypical active pharmaceutical ingredients 2017-11-29 16 Important reminders – Puerto Rico 2017-10-04 15 Importation of drugs for an urgent public health need 2017-07-05 14 Change to the Health Canada website 2017-06-08 13 Publication of Proposed Regulations Amending the Food and Drug Regulations (Vanessa’s Law) in Canada Gazette, Part I [2017-05-05] 2017-05-05 12 Publication of proposed regulations amending the Food and Drug Regulations (importation of drugs for an urgent public health need ) in Canada Gazette, Part I 2017-05-02 11 Certificate of pharmaceutical product and good manufacturing practice certificate annual fee increase 2017-03-31 10 Annual licence review product list 2017-02-03 9 Launch of the new pilot for sunscreen products 2017-01-27 8 Notice of consultation 2017-01-18 7 Implementation of a new pilot for sunscreens 2016-12-22 6 Reminder. Active pharmaceutical ingredient (API) application screening as of November 8, 2016 2016-11-08 5 Reminder. Table B for active pharmaceutical ingredients (APIs) 2016-11-08 4 Implementation of establishment licensing requirements for atypical active pharmaceutical ingredients 2016-11-04 3 Important notice to stakeholders regarding drug establishment licence applications submitted on portable storage devices 2016-09-20 2 Good manufacturing practices requirements for foreign buildings conducting activities in relation to active pharmaceutical ingredients destined for Canada or used to fabricate finished dosage forms destined for Canada 2016-08-04 1 Changes to the application process related to foreign buildings listed on drug establishment licences 2016-07-21The Regulatory Enrolment Process (REP) facilitates the filing and processing of regulatory information related to.

Company dossier what does viagra do and product regulatory activity regulatory transactionREP consists of web-based templates that capture information in a structured format. The REP templates replace existing Health Canada forms such as the HC-SC3011 drug submission application form and the human drug submission application fee form.This process enables a move towards a common submission intake across product lines and allows Health Canada to. Receive a broader range of regulatory information via the Common Electronic Submission Gateway (CESG) automate the import of regulatory transactions into its repositories REP Summary Table Product Line REP Status Non-Functional Pilot Functional Pilot Production (voluntary use) Mandatory Human Use Drugs (Pharmaceutical, Biologic and Radiopharmaceutical) and Disinfectants Closed Closed Closed Current (Implemented Oct.

2020) Medical Devices N/A Current (Expanded Mar.

Terminal sterilization processes for drugs 2021-05-03 111 Bonuses Canada and European how to order viagra Union - Recognition of good manufacturing practices extra-jurisdictional inspection outcomes 2021-04-22 110 Veterinary antimicrobial sales reporting 2021-03-04 109 Changes to the drug establishment licence exemptions for hand sanitizers 2021-03-02 108 Reminder. Cost-benefit analysis survey on proposed regulations due March 1, 2021 2021-02-18 107 CETA Regulatory Cooperation Forum – Stakeholder debrief meeting, February 10, 2021 2021-02-01 106 Health Canada nitrosamines webinar, February 10, 2021 2021-01-15 105 Transition measures for exceptional importation interim order 2021-01-25 104 Invitation stakeholder information session on the allocation of drugs accessed via exceptional importation 2021-01-19 103 Nitrosamine update to market authorisation holders of human pharmaceutical, biological and radiopharmaceutical products 2020-12-16 102 Consultation on the recommendations for interoperability of track and trace systems for medicines 2020-12-15 101 Brexit. Summary information for Canadian companies 2020-12-03 100 New interim order - Safeguarding the drug supply 2020-12-03 99 New erectile dysfunction treatment hold for certain DEL applications 2020-11-13 98 Health Canada is adding tools to help prevent and alleviate drug shortages related to the erectile dysfunction treatment viagra 2020-10-28 97 Notice of consultation (GUI-0026) 2020-10-07 96 Electronic issuance of pharmaceutical product and good manufacturing practices certificates 2020-10-01 95 New pathway to expedite the authorization for importing, selling and advertising of erectile dysfunction treatment drugs 2020-09-21 94 Notice of publication (GUI-0066 and GUI-0069) 2020-08-25 93 Notice of webinar (GUI-0069) 2020-08-13 92 Guidance.

Importing and exporting health products for commercial use (GUI-0117) 2020-08-13 91 Extension revised to complete risk assessments for nitrosamine impurities 2020-08-10 90 Notice of publication (GUI-0005) 2020-08-20 89 Coming into force of regulatory amendments (CUSMA) (June 30, 2020) 2020-06-30 88 Enhanced guidance to support submission of proposals for inclusion on List of Drugs for Exceptional Import and Sale 2020-06-25 87 Updated question and answer document regarding nitrosamine impurities 2020-06-12 86 Guidance on transportation and storage considerations 2020-05-15 85 Requests for Information on additional supply of certain drugs used in the treatment of erectile dysfunction treatment 2020-04-22 84 Guidance on business impact mitigation and additional measures for operational relief amid erectile dysfunction treatment 2020-04-16 83 Health Canada erectile dysfunction treatment update for health product licence holders 2020-04-09 82 Health Canada is taking action to quickly respond to potential drug shortages during the erectile dysfunction treatment viagra 2020-04-06 81 Electronic issuance of drug establishment licences 2020-04-02 80 Revised drug establishment licences (DEL) guides and form 2020-04-01 79 Information to market authorization holders (MAHs) of human pharmaceutical products regarding nitrosamine impurities 2020-03-27 78 Health product inspections and licensing blog 2020-03-27 77 Health Canada alleviates confirmatory and identity testing requirements for certain low-risk non-prescription drugs 2020-03-26 76 Canada announces interim drug product testing measures for licensed importers 2020-03-23 75 Approach to management of erectile dysfunction treatment 2020-03-17 74 erectile dysfunction treatment disinfectants and hand sanitizers 2020-03-17 73 Cost associated with foreign on-site assessments 2020-03-06 72 Notice of consultation (Annex 1) 2020-02-20 71 Important reminders (environmental crisis erectile dysfunction) 2020-02-19 70 Notice of consultation - Annex 4 to the good manufacturing practices guide – Veterinary drugs (GUI-0012) 2020-02-19 69 Small business training session 2020-02-19 68 ALR webex links 2020-02-05 67 Health Canada stakeholder information webinar - Nitrosamines in pharmaceuticals, January 31, 2020 2020-01-24 66 Introduction of telecommunication tools during GMP inspections 2020-01-17 65 CETA Regulatory Cooperation Forum - Stakeholder debrief meeting, February 4, 2020 2020-01-16 64 Follow-up to letter to drug establishment licence (DEL) holders to inform them about steps to take to avoid nitrosamine impurities 2019-12-05 63 Notice of consultation PIC/S GMP guide 2019-12-02 62 Management of applications and performance for drug establishment licences (GUI-0127) 2019-11-29 61 Training sessions on revised guidance documents related to the Fees in Respect of Drugs and Medical Devices Order 2019-12-29 60 Canada-EU CETA Civil Society Forum call for participation 2019-11-06 59 Migration of drug establishment licence (DEL) API foreign building data to the DEL database 2019-11-06 58 Terms and conditions relating to angiotensin II receptor blockers (ARBs), known as “sartans” 2019-11-06 57 Letter to market authorization holders of human pharmaceutical products to inform on steps to how to order viagra take to avoid nitrosamine impurities 2019-11-06 56 Transition period for new DEL requirements for active pharmaceutical ingredients (API) for veterinary use 2019-11-05 55 Revised fees for drugs and medical devices 2019-05-17 54 Survey on Canadian drug exportation 2019-05-02 53 Certificate of pharmaceutical product &. Good manufacturing practice certificate annual fee increase 2019-04-10 52 Health Canada’s fees for drugs and medical devices 2019-04-01 51 Best practices for submitting drug establishment licence (DEL) applications 2019-03-22 50 Stakeholder webinar presentation on the expanded sunscreen pilot 2019-02-18 49 Annual licence review webinar presentation and recording 2019-01-30 48 Pause-the-clock proposal webinar presentation and recording 2019-01-26 47 Additional Information regarding the expanded sunscreen pilot 2019-01-22 46 Presentation and recording on GUI-0031 webinar 2019-01-11 45 Notice to stakeholders – Release of good manufacturing practices for active pharmaceutical ingredients (GUI-0104) for consultation 2018-12-31 44 DEL annual licence review webinar 2018-12-21 43 Notice of consultation GUI-0069 2018-12-20 42 Notifying Health Canada of foreign actions - Guidance document for industry 2018-12-19 41 Launch of the expanded sunscreen pilot 2018-11-29 40 Webinar stop-the-clock 2018-11-28 39 Notice of consultation GUI-0028 &. GUI-0029 2018-11-21 38 Call of expression of interest 2018-11-14 37 Technical issue with the Drug &.

Health Product Inspection Database 2018-11-07 36 Inclusion of API in Australia-Canada Mutual Recognition Agreement 2018-11-01 35 Pause-the-clock proposal for drug and medical device establishment licence applications 2018-10-18 34 Introducing new blog 2018-10-15 33 Important reminders – Hurricane Florence 2018-09-27 32 Health Minister announces access to a U.S.-approved epinephrine auto-injector 2018-09-04 31 Stakeholder engagement seminars (GUI-0001) 2018-09-04 30 Notice of publication – GUI-0071 2018-07-10 29 Notice of consultation – GUI-0071 2018-07-05 28 Licensing requirements for reclassified high-level disinfectants and sterilants as medical devices 2018-07-23 27 Webinar GUI-0001 2018-06-01 26 Revised fee proposal for drugs and medical devices 2018-05-25 25 Important notice to stakeholders regarding revisions of drug establishment licensing guidance documents and forms as a result of amendments to the Food and Drug Regulations 2018-05-22 24 Antimicrobial regulatory amendment webinars affecting veterinary drugs – Drug establishment licensing and good manufacturing practices requirements 2018-03-29 23 GUI-0031 webinar 2018-03-15 22 Notice of publication 2018-02-18 21 Antimicrobial regulator amendment webinars affecting veterinary drugs – Health Canada 2018-02-07 20 GUI-0080 2018-01-09 19 Notice of consultation 2017-12-22 18 Pilot for sunscreen products 2017-12-21 17 Implementation of establishment how to order viagra licensing requirements for atypical active pharmaceutical ingredients 2017-11-29 16 Important reminders – Puerto Rico 2017-10-04 15 Importation of drugs for an urgent public health need 2017-07-05 14 Change to the Health Canada website 2017-06-08 13 Publication of Proposed Regulations Amending the Food and Drug Regulations (Vanessa’s Law) in Canada Gazette, Part I [2017-05-05] 2017-05-05 12 Publication of proposed regulations amending the Food and Drug Regulations (importation of drugs for an urgent public health need ) in Canada Gazette, Part I 2017-05-02 11 Certificate of pharmaceutical product and good manufacturing practice certificate annual fee increase 2017-03-31 10 Annual licence review product list 2017-02-03 9 Launch of the new pilot for sunscreen products 2017-01-27 8 Notice of consultation 2017-01-18 7 Implementation of a new pilot for sunscreens 2016-12-22 6 Reminder. Active pharmaceutical ingredient (API) application screening as of November 8, 2016 2016-11-08 5 Reminder. Table B for active pharmaceutical ingredients (APIs) 2016-11-08 4 Implementation of establishment licensing requirements for atypical active pharmaceutical ingredients 2016-11-04 3 Important notice to stakeholders regarding drug establishment licence applications submitted on portable storage devices 2016-09-20 2 Good manufacturing practices requirements for foreign buildings conducting activities in relation to active pharmaceutical ingredients destined for Canada or used to fabricate finished dosage forms destined for Canada 2016-08-04 1 Changes to the application process related to foreign buildings listed on drug establishment licences 2016-07-21The Regulatory Enrolment Process (REP) facilitates the filing and processing of regulatory information related to.

Company dossier and product regulatory activity regulatory transactionREP consists of web-based templates that capture information in a structured format. The REP templates replace existing Health Canada forms such as the HC-SC3011 drug submission application form and the human drug submission application fee form.This process enables a move towards a common submission intake across product lines and allows Health Canada to. Receive a broader range of regulatory information via the Common Electronic Submission Gateway (CESG) automate the import of regulatory transactions into its repositories REP Summary Table Product Line REP Status Non-Functional Pilot Functional Pilot Production (voluntary use) Mandatory Human Use Drugs (Pharmaceutical, Biologic and Radiopharmaceutical) and Disinfectants Closed Closed Closed Current (Implemented Oct.

2020) Medical Devices N/A Current (Expanded Mar.

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