CARPHA Meets with Regional Stakeholders to Discuss Post Market Surveillance for…

first_img CMO says Saint Lucia at critical stage of COVID-19 outbreak Patients assured safe, high quality drugs with establishment of Caribbean Regulatory SystemPort of Spain, Trinidad and Tobago.  April 7 2017.  The establishment of a Caribbean Regulatory System (CRS) will improve conditions for patients in the Region to receive safe, efficacious, high quality drugs.  Speaking at the Opening Ceremony of a Capacity-Building workshop on the Regulation of Medicines earlier this week, Executive…April 8, 2017In “CARICOM”CARPHA achieves international accreditation for testing quality of medicinesKingston, Jamaica – Access to healthcare and essential quality medicines and pharmaceutical products is critical for the Caribbean population’s well-being and optimal health. Recently, the Drug Testing Laboratory (DTL) of Caribbean Public Health Agency received international accreditation for laboratory testing services. Conformity with the ISO17025:2005 standard marks a significant endorsement for the…December 12, 2017In “General”CARPHA launches regional system for Member States to report sub-standard, falsified medicinesThe health of the Caribbean people can be at risk if medicines are not safe, effective and of good quality. Medicines safety and monitoring systems are often limited in the Region, and there has been a call for regional pooling of resources, sharing of information, and coordination of activities, that…February 2, 2018In “General”Share this on WhatsApp Share this:PrintTwitterFacebookLinkedInLike this:Like Loading… CARPHA Partners with, PAHO to Ensure Caribbean States’… Related Posts Six Eastern Caribbean countries deemed safe for travel – CDC Oct 16, 2020 (CARPHA Press Release) It is the right of all Caribbean people to have access to healthcare services, including essential quality medicines and pharmaceutical products they can trust. Poor quality and falsified medicines if left unchecked, can reverse progress the Region has made in its fight against diseases. “We live in a world where medicines are being developed and consumed at an increasingly higher rate; and there are increased findings of substandard and falsified medicines reported to global monitoring systems. We cannot have that proliferated in the Caribbean. Manufacturers are seizing the opportunity to import and flood markets in countries where medicines are of short supply or where the regulatory systems for medicines are weak. Thanks to CARPHA Medicines Quality Control and Surveillance Department (MQCSD) and its efforts to implement a “proactive, risk-based, planned sampling programme” for the post market surveillance of medicines, we are in a position to guard against this,” stated Dr the Honourable Christopher Tufton, Minister of Health, Jamaica. Minister Tufton was speaking at the opening of the CARPHA Meeting on Post Market Surveillance and the Caribbean Pharmaceutical Policy which is taking place from 12 – 13 March at the conference room of the MQCSD in Kingston, Jamaica. From left, Ms. Nicole Ennis, Quality Manager CARPHA-MQCSD, Dr. Virginia Asin-Oostburg, Director Surveillance, Disease Prevention and Control CARPHA, Dr. the Honourable Minister Christopher Tufton, Minister of Health Jamaica, Dr. Rudolph Cummings; Programme Manager, Health Sector Development, CARICOM; Ms. Jessie Schutt-Aine, Subregional Program Coordinator, Caribbean, PAHO/WHO; Ms. Sonia Thomas-Gordon, Acting Head, CARPHA-MQCSD Oct 16, 2020 Oct 16, 2020 He went on to say “The importance of the CARPHA MQCSD, as the only accredited medicines quality control laboratory in the English-speaking Caribbean, cannot be over stated. It is to the MQCSD that we now look to implement a Post Marketing Surveillance (PMS) strategy, that is, among other things, to provide test results that confirm the good quality of medicines or otherwise identify problems with them; and provide test results that give the opportunity for national medicines regulatory authorities to evaluate and make decisions on the actual quality of products used in country.” In closing, Minister Tufton stated “The systematic and emergency monitoring of medicines by CARPHA MQCSD through its PMS strategy, has the support of the Ministry of Health – recognising that its success is dependent on nurtured collaboration among Member States and key stakeholders, and on it being adequately resourced.” Other speakers at the opening ceremony were Dr Virginia Asin-Oostburg, Director, Surveillance, Disease Prevention and Control, CARPHA; Mrs. Jesse Schutt-Aine, Sub-regional Program Coordinator, Caribbean, PAHO/ WHO; and Dr Rudolph Cummings, Programme Manager, Health Sector Development, CARICOM Secretariat. In her welcome and opening remarks, Dr. Asin-Oostburg stated “This is the first meeting CARPHA is hosting with key regional partners of the Post Market Surveillance (PMS) programme that is organised by CARPHA’s Medicines Quality Control and Surveillance Department. We see this as an important milestone for CARPHA and its Member States. Since Jamaica is host country to CARPHA MQCSD, it is more than fitting to experience this milestone with our host. We consider this meeting, a milestone in repositioning what used to be the Drug Testing Laboratory and rebranding the laboratory as the Medicine Quality Control and Surveillance Department that also offers a surveillance programme to our Member States to actively monitor the safety of registered drugs. PMS is a programme developed by MQCSD that will further shape and form in collaboration with our partners and colleagues from Member States.” The importance of the CARPHA MQCSD as the only ISO/ IEC 17025 accredited medicines quality control laboratory in the English-speaking Caribbean, cannot be over-emphasized. The department has embarked on a post market surveillance programme for medicines, which seeks to monitor the quality of selected medicines circulating in the pharmaceutical markets of participating CARPHA Member States. This will ensure that Member States have access to information which can be utilized to develop evidence-based approaches such as issuing of alerts, implementing risk reduction strategies and overall management of national public health risks. Given the limited resources and other challenges facing small island developing states such as CARICOM countries, the responsibilities related to regulatory systems are difficult to carry out single-handedly or individually. In collaboration with other partners such as PAHO/WHO, CARPHA MQCSD will function as a critical part of a robust mechanism for regulating medicines in CARICOM. Ms. Schutt-Aine stated “PAHO is happy to be working with CARICOM and CARPHA and Member States on this initiative. Strong regulatory systems are the foundation for strong health systems. A strong health system is what’s needed for universal health, and universal health is essential for the attainment of the sustainable development goals. PAHO has been working on these issues for many years supporting the development of the Caribbean Pharmaceutical Policy, as well as a roadmap for a regional regulatory platform. More recently PAHO has been working closely with CARICOM and CARPHA and Member States to advance the Caribbean Regulatory Systems – the regional regulatory system that is managed by CARPHA. Ms. Schutt-Aine acknowledged “CARPHA as a regional public health platform that is transforming its drug testing laboratory into something that can enhance post market surveillance in the Region through risk based sampling of products in Caribbean markets.” The introduction of the new surveillance programme will allow CARPHA MQCSD laboratory to monitor medicines such as those used for the control of non-communicable diseases and other medicines. This programme is aligned with CARICOM’s strategy of advancing initiatives for health and wellness by ensuring access to safe, reliable medicines thereby improving the quality of life of the Region. The Caribbean region will have access to information to undertake evidence-based approaches to enable warning, risk reduction and management of national public health risks. Speaking at the opening, Dr. Cummings said, “The Medicines Quality Control and Surveillance Department needs to be complemented for the tremendous work that it has done to prepare for this meeting and in positioning itself to support the efforts require for a successful regional pharmacovigilance program.” Access to healthcare and essential quality medicines and pharmaceutical products is critical for the Caribbean population’s well-being and optimal health. Through dossier evaluation and pre-marketing quality control of generic medicines for the purpose of registration, some countries are ensuring that quality medicines are on the market. At the closing of the opening ceremony, Ms. Sonia Thomas-Gordon, Acting Head/Senior Chemist, CARPHA MQCSD, in her vote of thanks, acknowledged the commitment and endorsement by partners and participants to the MQCSD post surveillance programme. She said “Post market is a small component of pharmacovigilance, and the laboratory component is important. What we are trying to do is be proactive and monitor those medicines that are on the market. Most Member States do not have capacity to monitor and we are hoping to bridge the gap to have one central area, where medicines come to us for testing and we issue the results.” The two-day meeting will seek to sensitise CARICOM’s Technical Advisory Committee on Pharmaceutical Policy (TECHPHARM) and Caribbean Regulatory Systems (CRS) focal points on MQCSD’s post market surveillance programme with a view to strengthen regional integration and partnerships for sustainable development of the programme. The meeting will also aim to reaffirm the role of TECHPHARM in regional PMS and as a Technical Advisory Committee (TAC) to MQCSD. Also, down for discussion are the acknowledgement and endorsement of MQCSD’s PMS Strategy and Field Guide. More information about the CARPHA MQCSD can found read more

AYES Announces New Officers and Directors for 2011

first_imgLEESBURG, Va. — Automotive Youth Educational Systems (AYES) has announced its lineup of officers for its 2011 Board of Directors. AdvertisementClick Here to Read MoreAdvertisement Roger Foss, national field support manager, Toyota Motor Sales USA Inc. in Torrance, Calif., is chairman. Mike Durkin, director, Dealer Service & Warranty Operations, GM Customer Care & Aftersales in Warren, Mich., is vice-chairman. Gregory Settle, manager – Learning & Performance Operations, Mercedes-Benz USA LLC in Montvale, N.J., will serve as treasurer, and Monty Roberts, personnel recruiting and retention manager, BMW of North America, Woodcliff Lake, N.J., will serve as secretary.        “We are fortunate to have such a talented and dedicated group of individuals serving on the AYES Board of Directors,” said Chuck Roberts, AYES president and CEO. “Through their guidance, AYES has completed the reorganization begun last year and will continue to deliver the caliber of post-secondary student and entry-level technician that the service industry demands.”        New AYES board members include Durkin and Roberts, along with Steve Germain, president and CEO, Germain Motor Co., Columbus, Ohio, and Dan Vespertino, director-service operations, Subaru of America Inc., Cherry Hill, N.J.        AYES is a partnership among participating automotive manufacturers, the National Automobile Dealers Association, Automotive Trade Association Executives, State Departments of Education and Labor, local dealerships and select high schools across the country. The group’s goal is to encourage quality students with strong mechanical aptitude to pursue careers in the field of automotive technology and prepare them for entry-level positions in dealerships.last_img read more

Lauritzen: Life After 50 … It Takes A Village

first_imgBy BERNADETTE LAURITZENExecutive DirectorLARSO According to, , the saying, “It takes a village,” is a portion of an old African proverb. They also say that may be up for debate, too. Many times it does take a village to get things accomplished and I am thankful for my village. Finally, there’s Keith Yeske and Jim Zerr, that help me get everything else I need to check off the list, Bob Feagans and Yvonne Valencia, who keep me in line. Last, but not least are Donna Casados, Deni Fell and Eloisa Sanchez, who answer all of my questions and I am sure there are too many. They all make me look good when I don’t deserve it, but they complete the village and I thank them, so forgive me for being obsequious. Prior to the three-day audit, there were a few things outside the building to handle too. The crew from the Pavement Division stopped by to fix two of our, “Parking Bumps.” Did you know that’s what they call the concrete blocks you park your car tires against? I couldn’t get in, grab my camera, they were fixed and gone in a flash. Today, my focus is on the many cogs that help to keep this well-oiled machine running throughout the year. The sad part is, that I won’t be able to name everyone because it would take so long to get the names. Plus, I haven’t even met many of them, that’s why, it takes a village. This week, I wanted to focus on one of our many project partners at the Los Alamos Retired and Senior Organization. The community partner I have selected is Los Alamos County. Now, I realize that thanking a funder publicly may come across as being grossly obsequious, according to Come on, you should at least look up one word, plus I would get a chuckle knowing that you did just that.center_img I will continue, because I along with 20+ employees, wouldn’t get to do what we do, without them. Los Alamos County provides many services and buildings in the community that are run by local non-profits. Your local senior centers are just two of those locations. We service many people in the community with many programs, but I’ll elaborate on another day. I began May 1 and there has been some faced paced learning along the way. The first month, we did monthly fire drills, checked the AED machines weekly and many things not many people pay attention to, on a daily basis. These are now things that are my new routine and ones I feel like everyone needs to know about. Then there’s the gentleman that came to trim weeds near the sidewalks. I had even brought in a cooler of drinks, but he was done and gone before I even knew it. I had my first state audit and then first walk through with the Senior, Fire and Life Safety Coordinator, Stephen Rinaldi. Thanks to Rinaldi and Division Chief/Fire Marshal, Wendy Servey, we received our fire inspections upon request. It was an eye opening experience that sets the tone for an organization. We have a great guide and some education we can do for our members too.last_img read more

Profit growth drives Debenhams out of town

first_imgWould you like to read more?Register for free to finish this article.Sign up now for the following benefits:Four FREE articles of your choice per monthBreaking news, comment and analysis from industry experts as it happensChoose from our portfolio of email newsletters To access this article REGISTER NOWWould you like print copies, app and digital replica access too? SUBSCRIBE for as little as £5 per week.last_img

Rugged sensor available

first_imgSubscribe Get instant access to must-read content today!To access hundreds of features, subscribe today! At a time when the world is forced to go digital more than ever before just to stay connected, discover the in-depth content our subscribers receive every month by subscribing to gasworld.Don’t just stay connected, stay at the forefront – join gasworld and become a subscriber to access all of our must-read content online from just $270.last_img

ASCO grants Sodagem CO2 independence

first_imgSubscribe Get instant access to must-read content today!To access hundreds of features, subscribe today! At a time when the world is forced to go digital more than ever before just to stay connected, discover the in-depth content our subscribers receive every month by subscribing to gasworld.Don’t just stay connected, stay at the forefront – join gasworld and become a subscriber to access all of our must-read content online from just $270.last_img

McDermott Reports Net Loss in Third Quarter 2013

first_imgMcDermott International, Inc. (“McDermott” or the “Company”) reported a net loss of $64.1 million, or $0.27 per fully diluted share, for the quarter ended September 30, 2013. These results compared to income of $50.6 million, or $0.21 per fully diluted share, in the corresponding period of 2012.Weighted average common shares outstanding on a fully diluted basis were approximately 236.3 million and 237.9 million in the quarters ended September 30, 2013 and 2012, respectively.McDermott’s revenues were $686.9 million for the 2013 third quarter compared to $1,028.7 million in the corresponding period of 2012. The year-over-year decrease was primarily due to the completion of several significant projects that were active in the 2012 third quarter. The Company’s operating loss in the 2013 third quarter was $52.7 million compared to operating income of $82.5 million in the 2012 third quarter.“I am pleased to see our Middle East segment return to profitability this quarter as we demonstrated improved consistency in performance,” said Stephen M. Johnson, Chairman of the Board, President and Chief Executive Officer of McDermott. “Despite our recent challenges, I am optimistic about the future of the Company and the foundation that we have built to address the subsea market.”Operational UpdateIn the third quarter, all projects in the Middle East segment contributed to gross profit and were in a profitable position. In October, the Company reached a significant milestone on a previously discussed project in Saudi Arabia and demobilized the major workboats used for the hookup campaign, with the remaining commissioning scheduled for completion in the second quarter of 2014.On a deepwater Malaysian project in the Asia Pacific segment, the Company experienced vessel mechanical downtime that contributed to $66.0 million of additional project costs. The Company reached a commercial agreement with its customer totaling $33.0 million, partially offsetting the charge, which mitigates weather risk and late delivery penalties. As a result, the Company intends to maintain continuous operations through the monsoon season to install production-critical aspects of the project in 2013. The first of the four installation campaigns was completed in October and project completion is expected in the first half of 2014.In the Atlantic segment, a loss project at the Company’s Morgan City yard performed ahead of prior quarter estimates and is expected to be completed in the fourth quarter. A fabrication project in Mexico experienced estimated cost increases related to scope growth and schedule extensions during the quarter, resulting in a project loss of $9.0 million.The third quarter results include approximately $4.0 million of restructuring costs, for a cumulative total of $19.5 million. The Company expects to incur the majority of the remaining $35.5 to $45.5 million in planned restructuring and management charges in the next two quarters.Contract Backlog SummaryAt September 30, 2013, the Company’s backlog was approximately $4.6 billion, compared to $5.1 billion at June 30, 2013. Of the September 30, 2013 backlog, approximately $564.6 million was derived from four projects that are currently in a loss position. In addition, the backlog includes approximately $151.3 million for one project under deferred profit recognition.At the end of the third quarter, the Company had $9.0 billion in bids outstanding and is targeting approximately $8.9 billion in projects that the Company expects to bid within the next five quarters.Balance Sheet SummaryAs of September 30, 2013, McDermott reported total assets of approximately $3.2 billion. Included in this amount was $318.1 million of cash and cash equivalents, restricted cash and investments. Net working capital, calculated as current assets less current liabilities, was $226.6 million. In addition, total equity was $1.7 billion, or approximately 55% of total assets, with total debt of $94.1 million.Press Release, November 05, 2013last_img read more

Miller joins Tacoma

first_imgMiller brings more than 30 years of experience in IT to the role. Before joining the port, he served as vice president of IT at Weyerhaeuser Company. He will oversee the IT department at the port, which also supports The Northwest Seaport Alliance (NWSA). www.portoftacoma.comlast_img

Read of the Week

first_imgWalk the WireDavid BaldacciPan MacmillanReview: Karen Watkins Death, danger, a cult and a nail-biting plot, this novel has all the elements of a good thriller.The story takes place in the sleepy town of London, North Dakota. Hal Parker is closing in on his prey. He knows he’s nearing his target from the volume of blood, “like rubies scattered in the rich soil”. It’s hot and humid. A storm is brewing. Instead of a wolf, he comes across the body of a woman. The FBI are called in, the towns’ folk ask why. The woman has patterns on her chest, the tell-tale Y-incision cut used in an autopsy. The only problem is that she isn’t in a morgue but in the stark tundra of America’s fracking capital.At centre stage in the vast complicated cast of characters is FBI consultant Amos Decker. He is joined by former journalist and sidekick Alex Jamison. They work with local police boss Lieutenant Joe Kelly and coroner Walt Southern with professional assassins Will Robie and Jessica Reel joining in to investigate from behind the scenes. Robie and Reel feature in other Baldacci novels such as The Innocent and The Hit. As Decker and Jamison dig into the murder investigation, they discover that the woman was a prostitute by night and a teacher for a local religious sect by day. The sect operates on land once owned by a mysterious government facility.Despite the story taking place in America, fracking has been part of the South African narrative for the past few years. It continues, despite protests and lobby groups raising awareness about how this search for gas comes at the expense of this country’s most precious resource, water. This novel brings to light the seedier side of the industry.In retrospect I found the story quite tongue-in-cheek but enjoyed being taken for the ride. No wonder Baldacci is a favourite among crime and thriller writers. One lucky reader can win a hamper of three David Baldacci books: Long Road to Mercy; Redemption; and The Fallen. To enter, email your name, address and phone number to before midnight on Sunday August 23. Type “Baldacci” in the subject line.last_img read more

Chinese court poses ‘no immediate threat’ to London’s legal dominance

first_imgA new specialist financial court in China could enhance a ‘gravitational pull’ away from London, lawyers have said, though its immediate threat to the City has been downplayed.The Shanghai Financial Court, which specialises in finance disputes, opened on Monday.However UK lawyers told the Gazette that it should be welcomed rather than treated with caution as its focus, at least initially, will be domestic.Peter Dodge, barrister at Radcliffe Chambers, said although challenges to the primacy of London as a litigation centre are topical, the court does not yet fall into that category. The court, he said, is designed to merge various special financial tribunals in the current Shanghai court system. ‘As such, it looks essentially to be a domestic court.’‘That is not to say that it might not evolve into a body which increasingly seeks to apply English law in disputes with an international flavour,’ he added.Charles Pugh, partner at regional firm Oury Clark, said the new centre should not be seen as a threat because ‘it is always positive’ when specialised courts open but warned against complacency. He added that London’s standing has been built over time based on the ’stellar reputation’ of the judiciary here, the recognition of English law and the use of the English language.Khawar Qureshi QC, of Serle Court, said: ‘The emergence of rapidly expanding regional centres such as Singapore coupled with the increasing desire of parties to “go local” wherever possible means that London must avoid complacency and be more competitive to retain its position.’ He noted that Germany and France had also recently established English language based commercial courts to position themselves to draw disputes to them – at the potential cost of London.Charles Qin, head of the dispute resolution practice at Chinese firm Llinks Law Offices, said the court has a vision to handle ever-increasing financial cases and ’voice China’s judicial influence on the international stage’. ’The Court hears a wide variety of finance-related disputes and aims at providing a first class venue for financial dispute resolution,’ Qin added.According to news website ChinaDaily, the Shanghai court will handle disputes of a minimum value of RMB 100m (£11.4m) provided both parties are based in Shanghai and RMB 50m if one party is not based in the city. Cases that do not meet the minimum will be handled by district courts.last_img read more