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first_img Safety issues at compounding pharmacy underscore oversight problems Ed Silverman [email protected] Tags compounding pharmacyFDAgeneric drugspolicy Robert Cianflone/Getty Images Related: Please enter a valid email address. Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. About the Author Reprints In its latest to bid to set parameters around compounding, the US Food and Drug Administration last week issued a pair of draft guidelines to clarify when compounding pharmacies are permitted to make versions of commercially available medicines.Although federal law currently states that a compounder generally shouldn’t make copies of drugs that are approved for sale, the agency is getting more specific and wants to ensure that a true clinical need exists before a compounded version of an approved medicine drug is made for a patient.“The FDA is making a policy statement that you can’t just compound a copy and then market it,” said Elizabeth Jungman, director of public health at Pew Charitable Trusts, a nonprofit that studies health care issues. “There has to be a patient need. And it’s important from a safety perspective.”advertisement PharmalotFDA narrowly defines the ability of compounders to make approved medicines @Pharmalot By Ed Silverman July 11, 2016 Reprints A key issue has been the extent to which compounders can make medicines for patients in ways that may cross the line into more conventional drug manufacturing. The new law attempts to create boundaries, although the latest guidelines are designed to refine the FDA interpretation.For instance, the guidelines would permit compounders to make versions of brand-name drugs when a shortage exists or the brand-name medicine has been discontinued. Another example meeting the threshold of patient need might be a required change in formulation, such as different dosage strengths.But safety is not the only issue in play here. For instance, pointing to a lower price — in other words, a compounded version would be cheaper than a brand-name drug — is not justification for compounding an FDA-approved medicine.Brand-name drug makers would be less likely to invest in innovative medicines if a compounder — especially compounders that make large quantities of a medicine — is otherwise allowed to make and sell versions of treatments approved by the FDA, Jungman explained. Leave this field empty if you’re human: Similarly, generic drug makers may avoid seeking approval of copycat medicines if compounders can make copies of approved drugs, according to Robert Pollock, a former acting deputy director of the FDA Office of Generic Drugs, who now works at Lachman Consultants and advises drug makers.Of course, these are only draft guidelines — guidances in regulatory parlance — and are not set in stone. Manufacturers and others have an opportunity to comment. To date, the compounding industry has bristled at some restrictions contained in the new law.A spokeswoman for the International Academy of Compounding Pharmacists, an industry trade group, told us the guidelines are still being reviewed and that there is no comment at this time. The episode cast a harsh spotlight on compounders, as well as FDA and state oversight. In response, a federal law called the Drug Quality and Security Act was passed to beef up FDA authority to inspect facilities and enforce regulations.advertisement Indeed, there are ongoing safety concerns surrounding compounding pharmacies ever since a scandal erupted four years ago. That’s when injectable steroids made by a compounder in the Boston area were linked to 64 deaths and more than 750 cases of fungal meningitis around the country. Privacy Policy Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry.last_img read more

first_img Log in to Reply It seems cool. Deadline: 28 February 2014Open to: Graduate students preferably at postgraduate level. Preference will be given to ECML member states (Albania, Andorra, Armenia, Austria, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Iceland, Ireland, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Macedonia, Montenegro, Netherlands, Norway, Poland, Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden and Switzerland)Remuneration: €720 monthly allowanceDescriptionThe main role of the European Centre for Modern Languages (ECML), which is a body of the Council of Europe, is to serve in general the implementation of language policies and the promotion of innovative approaches to the learning and teaching of modern languages.The ECML offers traineeships, lasting in general 6 months. The 28 February application deadline is for the traineeship beginning in July. The trainees would work alongside the Centre’s international team of eight full-time staff members in the historic city of Graz. According to their field of interest applicants can choose the main area in which they would like to be involved (although the tasks will cover a wide variety of areas):organisation of events and meetings (Programme);documentation and resources (DRC);the Centre’s website (Website);finances and general administration (Administration).EligibilityQualifications and skills required of traineesgraduate or postgraduate studies preferably in the field of library and/ or information science;a very good knowledge of English or French and, if possible, a basic knowledge of German;accuracy, flexibility;good organisation and communication skills;adequate drafting and computer skills;motivation, ability to work efficiently in a team.Citizens of any of the Council of Europe member states, or of the enlarged partial agreement may apply for traineeships, however as the ECML is a Council of Europe partial agreement, preference is given to applicants from ECML member countries. This does not mean that students from non-member states cannot apply but applicants from member states are given priority, especially as a great number of applications are received prior to every selection period.The ECML member states are as follows: Albania, Andorra, Armenia, Austria, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Iceland, Ireland, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Macedonia, Montenegro, Netherlands, Norway, Poland, Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden and Switzerland.RemunerationTrainees receive a subsistence allowance of approximately €720 per month, which is transferred by the Council of Europe at the end of each month.  From this, a deduction of approximately € 20 is made each month from the trainees allowance to cover the costs of insurance during the stay.No contribution is made by the ECML towards travel costs from the trainee’s home country to and from Graz.ApplicationTo apply fill in the application form (available HERE) and upload it online HERE by 28 February 2014.Check also the FAQ section HERE for more details.For more information, please visit the official website HERE. Tweet ← Internship Program at Asian Development Bank LinkedIn 0 Share 0 Log in to Reply By Amela says: Reddit Pocket on December 17, 2013 at 11:52 am 3 thoughts on “European Centre for Modern Languages Traineeships” Similar Stories By Mikiyas says: Hi and what about the citizens of Kosovo can we apply to this project or not. And when not can we apply as a citizen of Albania. Thank you. Apply to CEU and Study in Vienna with a Scholarship December 17, 2013 Published by austin on December 17, 2013 at 12:32 pm on December 17, 2013 at 12:53 pm Apply to CEU and Study in Vienna with a Scholarship Log in to Reply European Centre for Modern Languages Traineeships is it possible to apply if you are a postgraduate student of Public Administration…thanks for response Call for Entries: Pro Carton Young Designers Award 2021 By Michael says: +1 Leave a Reply Cancel ReplyYou must be logged in to post a comment. World Press Photo Contest →last_img read more

first_imgBioTek Instruments,Vermont Business Magazine BioTek Instruments, based in Winooski, continues to strengthen its commitment to sustainability by joining the over 1,200 governors, mayors, businesses, investors, and colleges and universities from across the US who have voiced their intent to continue to ensure the US remains a global leader in reducing carbon emissions. By declaring that ‘we are still in,’ BioTek and the other signatories are putting the best interests of their constituents, customers, students and communities first while assuring the rest of the world that American leadership on climate change extends well beyond the current federal government.The science is clear. The planet’s environment is changing, and this is largely due to human activity. It is also clear that the impact on earth’s inhabitants, including people, will be negative. The only question is the magnitude of the impact, and exact timing.BioTek’s Vice President, Adam Alpert noted, “BioTek is committed to decreasing its carbon foot print by focusing both on energy efficiency and renewable sources for power. Its new solar facilities in Whiting and Milton, Vermont, for example, offset 100% of the company’s electrical energy cost. This is one of many existing company-wide programs promoting energy conservation, recycling, and environmental protection. We are demonstrating leadership through action, and at a critical time. Locally and in partnership with the many governments, companies, and institutions dedicated to reducing carbon emissions, we are taking steps that will help achieve the bigger goal — a cleaner and safer environment around the world.”Vermont’s largest, locally based Tech firm ($118 million in revenue. Vermont Business Magazine January 2017) BioTek Instruments, Inc, headquartered in Winooski, VT, USA, is a worldwide leader in the design, manufacture, and distribution of innovative life science instrumentation. Our comprehensive product line includes cell imaging systems, microplate readers, washers, dispensers, automated incubators, stackers and pipetting systems. These products enable life science research by providing high performance, cost-effective analysis and quantification of biomolecules, biomolecular interactions and cellular structure and function across diverse applications. BioTek espouses a “Think Possible” approach that sets the tone for fresh ideas, unsurpassed customer service and original innovations. VBM vermontbiz.comSource: June 14, 2017, WINOOSKI VT, USA — BioTek Instrumentslast_img read more

first_imgPSC Golf from The Outback Golf BarMonday, April 13, Burapha A & B – StablefordThis year was the second Songkran that the Outback decided to play a home three-day tournament instead of going on tour, as many other societies choose to do.  The chosen courses were Burapha on Monday, Phoenix (Tuesday) and the final round at Khao Kheow on Thursday. We had a good turnout for the first day, considering that so many golfers were away, with 32 players were out on the A & B nines, twelve of them going on to play in all three days.Leading money winner Peter Nixon did the business again with a very fine 40 points to win Division A by four from Andre Coetzee (36), while Geoff Stimpson (35) took third and Phil Mitchell beat Mike Missler on c/b for fourth, both on 34. From left: Suzi Lawton, Tim Knight, Sugar Ray Handford and Peter Nixon.Division B went to Mathias Herman with the day’s second best score of 41 points, two clear of Jimmy Little who in turn was six ahead of Brian Wilkinson and Pat Regan tied on 33’s, with Brian getting the nod on c/b.The day’s top score came from Geoff Treloar, who had been here since the start of our Hua Hin tour but has rarely appeared on any of the leader-boards.  Geoff plays virtually every day when he is here on holiday but barely hits the ball more than 150 yards off the tee; last year we moved him up to the Silver Tee at Black Mountain where he produced a much better result.  It wasn’t until earlier this month, when we docked him four shots and put him off the silver tees at Phoenix that he won with 37 points, and he did it again today, having his last game before flying home he registered 42 points to take Division C.  Well done mate!Bob Lindborg & Barney both had 36’s and Tim Knight 35.There were four ‘2’s from Pat Regan (A6) and Andre Coetzee, Peter Hausberger & Ivan Plunkett (B3).Outback opinion: Weather – light cloud, cool breeze; Check in – friendly as always; Tee time – early; Fairways – hard, fast; Rough – light; Greens – average; Bunkers – well raked; Value for money – good; Pace of play – under four hours; Drink stations open – all open; Restaurant – not visitedDiv A (0-12)1st Peter Nixon (10) 40pts2nd Andre Coetzee (07) 36pts3rd Geoff Stimpson (08) 35pts4th Phil Mitchell (05) 34ptsDiv B (13-20)1st Mathias Hermann (15) 41pts2nd Jimmy Little (20) 39pts3rd Brian Wilkinson (20) 33pts4th Pat Regan (13) 33ptsDiv C (21+)1st Geoff Treloar (31) 42pts2nd Bob Lindborg (27) 36pts3rd Barney Clarkson (29) 36pts4th Tim Knight (30) 35ptsTuesday, April 14, Phoenix – StablefordAnother fabulous turnout of 28 players on a not so hot Songkran holiday gathered at Phoenix to play the Mountain and Ocean courses.  We got off to an early start with 3 groups on Mountain and 4 on Ocean.The greens on the Mountain course have recently been cored and sanded, which presented conditions less than ideal in comparison to the fabulous greens experienced at Burapha. However, Phoenix continues to provide good value and the necessary work done now will pay dividends in the next weeks and months as we continue our outings at this venue.On Day 2 of our Songkran tournament, we had three divisions with some great scores coming in, especially for the higher handicap divisions.Tim Knight said he was very relieved to play on greens so different from Burapha as it required less skill and he consequently finished with a fabulous 40 points, taking the third division honours.Division 2 was won by Eddy Beilby with 38 points and Division 1 went to Peter Nixon with 37, leading the field by 4 shots.  Peter is proving to be the most consistent player on his handicap as his good form continues. Well done to all our winners!After two days the leader-board looked like this: Peter Nixon (77), Tim Knight (75), Jimmy Little (69), Eddy Beilby (67) with Bruce McAdam and Geoff Stimpson both on 66.There were six ‘2’s from Peter Hausberger (M4), Geoff Stimpson & Barry Copestake (M8), Greg Barry & Mike Missler (O5) and Bill Hewitt (O7).Div A (0-11)1st Peter Nixon (09) 37pts2nd Greg Barry (09) 33pts3rd Andre Coetzee (06) 31ptsDiv B (12-19)1st Eddy Beilby (17) 39pts2nd Norm Cheetham (14) 37pts3rd Bill Hewitt (16) 35ptsDiv C (20+)1st Tim Knight (28) 40pts2nd John Langley (22) 39pts3rd Suzi Lawton (23) 32ptsThursday, April 16, Khao Kheow C & A – StablefordAfter resting on Wednesday, the last of three-day Public Holiday, we were at Khao Kheow today for the final round of our tournament.  The weather continued to behave itself, as it did all week and Khao Kheow was once again beautifully presented.Sugar Ray emerged from a three week break from golf to prove that he has lost none of his passion for this course and racked up a fantastic 42 points, which is no mean feat round here.  It was the day’s top score and gave him the win in Division B, six ahead of Murray Tompsett in second and Suzi Lawton, third.John O’Keefe won Division A with 37 points ahead of Kim Danboise (35) but our 2 day tournament leader, Peter Nixon, crumpled under pressure and could manage only 28 round this tricky track and that left the door wide open for Tim Knight, who doesn’t even like this course, to walk right through and score 34 points to win the overall.There were no ‘2’s.Div A (0-18)1st John O’Keefe (17) 37pts2nd Kim Danboise (12) 35pts3rd Eddy Beilby (18) 34pts4th Pat Regan (13) 34ptsDiv B (19+)1st Sugar Ray Handford (21) 42pts2nd Murray Tompsett (20) 36pts3rd Suzi Lawton (25) 36pts4th Tim Knight (28) 34ptsOverall Result1st Tim Knight 112pts2nd Peter Nixon 107pts3rd Eddy Beilby 102ptsT4th Suzi Lawton 99ptsT4th Jimmy Little 99ptsNote: The Outback Golf Bar is situated about 6km from Sukhumvit Road along Soi Siam Country.  Call Jack on 081 578 1956.last_img read more

first_imgThe Swan440023128 i-Rovers ‘A’410318212 The Clinic410318182 i-Rovers ‘Casuals’420220264 Rising Sun420220184 2 Dogs Bar420216194 Standings April 3 (week 4)center_img TeamPWDLFAPts. Londoner440028158 W. Tankies410311242 Crazy Eddie’s430124196 Nervous Wreck400418240last_img

first_imgBy RUSSELL BENNETT BEHIND every ultra-marathoner, is a team of dedicated Pakenham Voyage Fitness members spurring them on … Isn’t…[To read the rest of this story Subscribe or Login to the Gazette Access Pass] Thanks for reading the Pakenham Berwick Gazette. Subscribe or Login to read the rest of this content with the Gazette Digital Access Pass subscription.last_img

first_imgFront to back, Brodie Green, Hannah Whelan, Karen Alarcon, Bryony Jackson, Nicole Hallett, Madeline Jones, Samantha Lastro and Elyyce Boulter…[To read the rest of this story Subscribe or Login to the Gazette Access Pass] Thanks for reading the Pakenham Berwick Gazette. Subscribe or Login to read the rest of this content with the Gazette Digital Access Pass subscription.last_img

first_imgBy ANEEKA SIMONIS A PAKENHAM school has remained tight-lipped over a claim by a special-needs student who said he was…[To read the rest of this story Subscribe or Login to the Gazette Access Pass] Thanks for reading the Pakenham Berwick Gazette. Subscribe or Login to read the rest of this content with the Gazette Digital Access Pass subscription.last_img

first_imgBy The Nelson Daily SportsA pair of Nelson Selects Rep squads made the short trek across the 49th parallel to compete in the Coeur d’Alene Youth Soccer Tournament this past weekend.The Nelson U14 girl’s and U15 boy’s experienced mixed results at the two-day event.U14 Girl’s DivisionThe Nelson Selects found it very difficult to find goals in Coeur d’Alene, going scoreless in three games.“(Two games) Nelson dominated . . . but could not get the ball into the net,” said a team spokesperson.The Selects opened the tourney with a scoreless tie against Helena Arsenal of Idaho.Game two was against an impressive North Idaho Avalanche squad, consisting mostly of 15-year-old players.Nelson was definitely up against it against the Avs, losing 7-0.In game three, the Nelson defence turned up the tempo but the offence failed to produce once again as the Selects played to a scoreless tie against Sandpoint Strikers.U15 Boy’s DivisionThe Nelson Selects, coached by Scott Lewis, tied two and lost a 1-0 heartbreaker to finish out of the playoffs in the U16 Boy’s Division in Coeur d’Alene.The 1-0 loss came thanks to a controversial call by the referee, awarding the opposition a penalty shot.The week before in Trail, the Selects edged Cranbrook 2-1 to claim the top prize in the Kootenay South Tournament.Dylan Whiffen and Daniel Rodman scored for Nelson.The Selects advanced to the final by stopping host Kootenay South 1-0 and a much-improved Creston team [email protected]last_img read more

first_imgClaregalway Hotel/Bon Secours Hospital Senior Football Championship – Group 1St. James 2-18 An Cheathrú Rua 2-13Claregalway 1-15 Cortoon Shamrocks 1-13 Claregalway Hotel/Bon Secours Hospital Senior Football Championship – Group 2Salthill-Knocknacarra 2-13 Barna 0-8Killannin 1-16 Tuam Stars 3-7 Claregalway Hotel/Bon Secours Hospital Senior Football Championship – Group 3Killererin 2-12 Kilconly 1-9Caherlistrane 1-13 Naomh Anna, Leitir Mór 2-7Claregalway Hotel/Bon Secours Hospital Senior Football Championship – Group 4Milltown 3-13 Moycullen 1-9St Michael’s 2-13 Caltra 1-8Ocean Hygiene Supplies & Packaging U12 Hurling Group 5 ShieldAbbeyknockmoy 2-4 Padraig Pearses 2-0Ocean Hygiene Supplies and Packaging U13 A Hurling ChampionshipTurloughmore 3-6 Clarinbridge 2-1Claregalway Hotel/Bons Secours Intermediate Football Championship – Group 1Oranmore-Maree 2-11 Menlough 2-5Williamstown 1-14 Glenamaddy 1-6Claregalway Hotel/Bons Secours Intermediate Football Championship – Group 2An Spidéal 2-16 St Brendan’s 0-8Micheál Breathnach 1-8 Oughterard 0-10Claregalway Hotel/Bons Secours Intermediate Football Championship – Group 3Dunmore MacHales 1-11 Clifden 1-10Kilkerrin-Clonberne 3-14 St Mary’s GAA Athenry 2-8Claregalway Hotel/Bons Secours Intermediate Football Championship – Group 4Headford 5-17 Carna-Caiseal 2-3Oileann Arainn 2-14 St. Gabriels 1-8WERS Waste U14 Football Division 1 NorthMountbellew/Moylough 0-0 St Mary’s GAA Athenry 0-0Ocean Hygiene Supplies & Packaging Under 15 A1 Hurling Championship – Group 1Kilnadeema-Leitrim 7-15 Ballinasloe 0-5Intermediate Hurling Championship – Group 1Annaghdown 2-17 Castlegar 0-12Killimor 0-17 Kilconieron 1-12Kiltormer 3-13 Kilbeacanty 0-13Gullane’s Hotel Junior A Hurling ChampionshipSt Mary’s GAA Athenry 1-15 Clarinbridge 1-14Sarsfields 2-18 Craughwell 0-14WERS Waste U13 Football Division 3 BCaltra 4-8 Killererin 2-9Junior Championship North – Group AMountbellew/Moylough 3-10 Annaghdown 1-7Junior Championship West – Group AAn Fhairche – Clonbur W/O St Michael’s –Moycullen 2-10 St. James 2-7Junior Championship West – Group BRenvyle 2-15 Salthill-Knocknacarra 3-9Claregalway W/O Micheál Breathnach –Junior Football ChampionshipTuam Stars 0-10 Milltown 0-10WERS Waste U12 Football Group 2Dunmore MacHales 3-14 Annaghdown 1-4WERS Waste U12 Football Group 6Northern Gaels 1-6 Kilconly 0-7WERS Waste U12 Football Group 8An Fhairche – Clonbur 4-10 Naomh Anna, Leitir Mór 4-9Junior A Championship West – Group AFr Griffins/Eire Óg 1-9 Na Piarsaigh 2-6Barna 1-11 Oughterard 0-6Junior A Championship West – Group BKillannin W/O Naomh Anna, Leitir Mór –An Cheathrú Rua W/O Salthill-Knocknacarra –Junior A Football ChampionshipPadraig Pearses 1-20 Monivea-Abbey 2-13Corofin 5-14 Glinsk 1-6Gullane’s Hotel Junior B Hurling ChampionshipKillimor 2-16 Loughrea 1-10Oranmore-Maree 0-16 Killimordaly 0-15Junior B Football ChampionshipMenlough 2-15 Claregalway 2-11Gullane’s Hotel Junior C Hurling ChampionshipKilbeacanty 0-11 Sarsfields 0-7Junior C Championship North – Group AAnnaghdown 0-17 Corofin 1-8Gullane’s Hotel Junior C1 Hurling ChampionshipKilnadeema-Leitrim 4-10 St Thomas 1-12Mullagh 1-11 Kinvara 1-3Pier Head Minor A Hurling Championship – Group 2Turloughmore 3-25 Salthill-Knocknacarra 1-11Pier Head Minor B1 Hurling Group 1Sarsfields 4-25 Portumna 5-8Ahascragh/Fohenagh 1-22 Ballinderreen 2-10Ahascragh/Fohenagh 2-27 Portumna 2-9Pier Head Minor B1 Hurling Group 2Cois Fharraige 3-11 Ballinasloe 1-12print WhatsApp Facebook Twitter Emaillast_img read more