Live Webinar on US, EU and Japan GMP Requirements: Practical ...

Houston, TX, August 16, 2012 ?(PR.com)? This 90 minute webinar will help you gain a detailed overview of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will help prepare you for regulatory inspections in these countries.

Why Should You Attend?

This ICH GMP training course will provide your company the opportunity for a detailed overview of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).

It will cover the key areas of how ICH was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.

Agenda: (All time in EST):

- 1:00-2:15 pm (Course Delivery)
- 2:15-2:30 pm (Q&A Session)

Areas Covered in the Seminar :

US, EU, Japan GMP Requirements (Practical ICH Area Differences, Healthcare Authority Inspection Focus)

I . U.S., EU and Japan GMPs ? Status of Harmonization and Where We're Heading
- Current efforts to further harmonize GMP requirements.
- Future expectation & likely progress.

II . Where Inconsistencies Become a Problem: WHO, ICH, Countries
- Flexibility in global expectations.
- Most challenging topics where alignment varies.

III . Key Chapter Reviews
- ICH GMP organization.
- Category reviews.

IV . Compliance with ICH Guidelines for GMPs
- Understanding and Insight into Healthcare Authority expectations
- How GMP requirements / inspections can differ with a single ICH Standard.
- How regulators (from 3 regions) will assess / enforce compliance with

Q7.
V . GMP Comparisons for APIs
- Auditing API facilities.
- Typical audit agenda.
- ICH Area differences.

VI . GMP Comparisons for Finished Products
- Auditing finished product facilities.
- Typical audit agenda.
- ICH Area differences.

VII . GMP Comparisons for ??
- Excipients.
- Sterile products.
- Biologics.
- Clinical Packaging.

VIII . Differences on Area GMP Inspections
- Differences on how GMP inspections are conducted.
- Areas of GMP inspection focus by area.
- Modifying your self-inspection systems to customized area concerns.

IX . Outsourcing Management ? a Regional Perspective on:
- Contract manufacturing.
- Contract packaging.
- 3rd Party Contract testing.

X . Auditing Your Facilities for Global Considerations
- Importance of pre-audits to regional GMP focus.
- How to focus your internal audits to a US, EU and Japan compliance system.

Who Will Benefit:

This Webinar will provide valuable assistance to all License Owner personnel in the Pharmaceutical, Biotechnology and Combination Products areas, including contract manufacturers, packagers and suppliers. Particular functional expertise receiving value from attending would be:

- Manufacturing
- Quality Assurance
- Senior management
- Project Managers
- Qualified Persons (QPs)
- Regulatory Compliance
- CMC Personnel
- Packaging Experts
- Auditors and Staff
- Consultants

About Speaker

Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.

Contact Information:
Compliance2go
Jay Syvester
877-782-4696
Contact via Email

https://compliance2go.com/index.php

Click here to read the full story: Live Webinar on US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus by Compliance2go

Press Release Distributed by PR.com

Source: http://health.rambergmedia.com/live-webinar-on-us-eu-and-japan-gmp-requirements-practical-ich-area-differences-healthcare-authority-inspection-focus-by-compliance2go/

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Polar bear's death linked to ... zebra herpes?

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Germany's Bosch plans to shorten work hours due to slack demand

FRANKFURT (Reuters) - German industrial group Robert Bosch GmbH is in talks with workers at its engineering unit, Bosch-Rexroth, to cut their work hours in response to weakening demand from industrial customers, a company spokesman said on Friday.

Bosch-Rexroth is one of the world's leading producers of drives, valves and control technologies, which are used in machine cutting tools and in the automotive and wind energy sectors.

Stuttgarter Zeitung newspaper, quoting labor sources, said shorter hours at the Bosch-Rexroth factory in Schweinfurt, Germany, might be implemented in October, initially affecting 450 to 500 workers. By year-end, 1,100 workers may be affected, the newspaper reported in its Saturday edition.

The Bosch spokesman said customers in the automotive industry were placing fewer orders for diesel systems, slowing down production at plants in Homburg, Stuttgart-Feuerbach and Bamberg.

But these plants are not considering launching a short-work program because workers could reduce their hours by using up vacations and time off accrued from working overtime, the spokesman added.

Automotive component supplier ZF Friedrichshafen is also seeing the first signs of slowing demand. A spokesman for ZF said orders and production at its commercial vehicle business were easing, but plant usage at its passenger car operations was still good.

He said ZF had no plans to launch a short-work program but was still using up accrued time off and vacations.

(Reporting By Hendrik Sachmann and Hans Seidenstuecker; Writing by Marilyn Gerlach; editing by John Wallace)

Source: http://news.yahoo.com/germanys-bosch-plans-shorten-hours-due-slack-demand-192414901--finance.html

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Children?s self-control is associated with their body mass index as adults

ScienceDaily (Aug. 13, 2012) ? As adults, we know that self-control and delaying gratification are important for making healthful eating choices, portion control, and maintaining a healthy weight. However, exhibiting these skills at a young age actually may affect weight later in life. A new study scheduled for publication in The Journal of Pediatrics finds that delaying gratification longer at 4 years of age is associated with having a lower body mass index (BMI) 30 years later.

Between 1968 and 1974, 653 4-year-olds completed a delay of gratification test, in which the children were given one treat, such as a cookie or a marshmallow, and were told that they would be given a second treat if they could wait to eat the first treat for an unspecified length of time (it ended up being 15 minutes). Follow-up studies found that delaying gratification for a longer time as a preschooler was associated with adolescent academic strength, social competence, planfulness, ability to handle stress, and higher SAT scores. According to Tanya R, Schlam, PhD, from the University of Wisconsin School of Medicine and Public Health's Center for Tobacco Research and Intervention, "Interventions can improve young children's self-control, which may decrease children's risk of becoming overweight and may have further positive effects on other outcomes important to society (general health, financial stability, and a reduced likelihood of being convicted of a crime)."

A video of children trying to delay gratification can be found at http://www.youtube.com/watch?v=6EjJsPylEOY.

To further assess the adult benefits of childhood self-control, Dr. Tanya Schlam and colleagues from University of Washington, Columbia University, and University of California, Berkeley, followed-up with study participants (164 responded; 57% female), who are now in their mid-30s, to assess their current BMI (an indicator of body fat), which was cross-referenced with how they did on the delay of gratification test as children. The researchers found that each minute a child delayed gratification predicted a 0.2 decrease in adult BMI. Only 24% of the respondents were overweight and 9% were obese, which is lower than the 2008 national adult average of 34% overweight and another 34% obese.

Fortunately, self-control can be modified and improved. Because large portions and tempting, high-calorie foods usually are readily available (often more so than healthy foods), developing high self-control and ability to delay gratification, along with using other strategies and interventions, can be helpful in regulating caloric intake and achieving a healthy weight, in both children and adults.

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Story Source:

The above story is reprinted from materials provided by Elsevier, via AlphaGalileo.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.


Journal Reference:

  1. Tanya R. Schlam, Nicole L. Wilson, Yuichi Shoda, Walter Mischel and Ozlem Ayduk. 'Preschoolers? Delay of Gratification Predicts Their Body Mass 30 Years Later. The Journal of Pediatrics, 2012 DOI: 10.1016/j.jpeds.2012.06.049

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

Source: http://feeds.sciencedaily.com/~r/sciencedaily/most_popular/~3/k5v7_KXozO0/120816075413.htm

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10 Questions To Ask In Your Nursing Home ... - Retirement Homes

It?s no secret that seniors are the fastest-growing age demographic across North America. And this growing clout of this age bracket means it?s becoming easier to find products and services specially-made for seniors and older people.

But sometimes too much selection can become hard to navigate. When it comes to finding the perfect nursing home for your parent, for example, where do you begin? There are more than 16,000 nursing homes in the United States housing nearly two million beds ? that?s an intimidating number.

But when beginning your search, here?s a list of the 10 things you questions you need to answer to help? find the best residence for your parent:

1/ Where does your parent?s family, including you, live? It?s an important consideration in deciding where to look first if your family lives in one state, but your parent wants to move to the other part of the country. It?s not impossible, but consider the time, expenses and emotional cost of constantly going to visit hundreds of miles away. Are there any closer options?

2/ What kind of care does your parent need? If your parent is able to feed, clothe, bathe and toilet themselves, but only requires minor assistance, than perhaps a nursing care community isn?t right for them. Instead, an independent living community might be a better option. When you visit local facilities, ask their staff what level of care they offer.

3/ What?s your budget? When evaluating how much you can afford, ask yourself how much money your parent has saved, and how long that might last. Additionally, look into whether the residence has any financial aid possibilities, or whether there are non-profit alternatives.

4/ How many doctors or nurses are at the nursing home at any time? When there?s a medical emergency, it?s good to know that there are health professionals in the same building instead of a 10 minute drive away. It?s also worth asking the nursing home what kind of medical equipment is at the home.

5/ What kind of activities are offered? Multiple studies have shown that exercise ? both physical and mental ? can assist in strengthening cognitive abilities, both among seniors and the general public. If your parent is suffering from the early stages of dementia, make sure that the nursing home options you?re considering offer excellent opportunities for your parent to strengthen their brains and their bodies.

6/ What do the meals look like? A healthy, nutritious meal can make a big difference for someone with chronic pain and discomfort, so make sure that your parent has meals they look forward to, and are also good for them.

7/ What do the residents and their families think? When you?re on a tour or visit, ask to speak to residents. If that?s not permitted, ask for the contact info of families of residences. They will be honest about their experiences, and will help you in your decision-making process.

8/ Are there enough pull cords? Falls among seniors are common, including in bathrooms. So when you?re in for a visit at the nursing home, take a look at the bathroom and see whether there are pull cords near the toilet and bathtub, and if so, who is alerted when the cord is pulled. No matter where your parent is, you want them to be safe.

9/ How large is the community? There are benefits of both larger and smaller homes, but much depends on personal preferences. Smaller homes may provide a homier atmosphere where residents are all known personally; larger ones may provide better amenities and healthcare options. It?s your decision, but think about it.

10/ What does your parent think? It?s great to compare and contrast the benefits and drawbacks of various nursing homes, but in the end it comes down to what you and your parent think. If you think one location is best, but your parent strenuously disagrees, then maybe it?s not right for them. Ask them, and be open.

Retirement Communities near You Other Locations?

  • The Kenwood of Lake View provides a full range of choices for today?s seniors. Choosing a senior living community represents a lifestyle choice and we ...

  • Holley Court Terrace provides a full range of choices for today?s seniors. Choosing a senior living community represents a lifestyle choice and we understand ...

  • Located in the beautiful Chicago suburb of Palos Park, Peace Village is a not-for-profit senior living community committed to providing people from all ...

  • Nestled in the heart of downtown Des Plaines on River Road, The Heritage provides the security and warmth of small-town living with easy access to everything ...

  • Now open in Geneva, independent senior living at GreenFields is not like any other option you'll find. At GreenFields, you'll love our hospitality, our ...

  • The Seasons at Glenview Place provides a full range of choices for today?s seniors. Choosing a senior living community represents a lifestyle choice ...

  • The Devonshire Of Hoffman Estates provides a full range of choices for today?s seniors. Choosing a senior living community represents a lifestyle choice ...

  • Nestled in a beautiful, wooded area and surrounded by impeccably manicured grounds, The Devonshire is the perfect place to call home. Knowing we provide ...

  • The Hallmark provides a full range of choices for today?s seniors. Choosing a senior living community represents a lifestyle choice and we understand ...

  • 850 Lake Shore Drive will soon be an exquisite retirement community that enriches the lives of active seniors. Set in Chicago's distinguished Streeterville ...

Search for a Retirement Community

Source: http://www.retirementhomes.com/library/10-questions-to-answer-in-your-nursing-home-search/

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Pan-fried meat increases risk of prostate cancer, new study finds

ScienceDaily (Aug. 16, 2012) ? Research from the University of Southern California (USC) and Cancer Prevention Institute of California (CPIC) found that cooking red meats at high temperatures, especially pan-fried red meats, may increase the risk of advanced prostate cancer by as much as 40 percent.

Mariana Stern, associate professor of preventive medicine at the Keck School of Medicine of USC, led analyses for the study, "Red meat and poultry, cooking practices, genetic susceptibility and risk of prostate cancer: Results from the California Collaborative Prostate Cancer Study." The study, which is available online in the journal Carcinogenesis, provides important new evidence on how red meat and its cooking practices may increase the risk for prostate cancer.

Previous studies have emphasized an association between diets high in red meat and risk of prostate cancer, but evidence is limited. Attention to cooking methods of red meat, however, shows the risk of prostate cancer may be a result of potent chemical carcinogens formed when meats are cooked at high temperatures.

Researchers examined pooled data from nearly 2,000 men who participated in the California Collaborative Prostate Cancer Study, a multiethnic, case-control study conducted in the San Francisco Bay Area by Esther John, CPIC senior research scientist, and in Los Angeles by Sue A. Ingles, associate professor of preventive medicine at the Keck School of Medicine of USC. Study participants completed a comprehensive questionnaire that evaluated amount and type of meat intake, including poultry and processed red meat. Information regarding cooking practices (e.g., pan-frying, oven-broiling and grilling) was obtained using color photographs that displayed the level of doneness. More than 1,000 of the men included in the study were diagnosed with advanced prostate cancer.

"We found that men who ate more than 1.5 servings of pan-fried red meat per week increased their risk of advanced prostate cancer by 30 percent," Stern said. "In addition, men who ate more than 2.5 servings of red meat cooked at high temperatures were 40 percent more likely to have advanced prostate cancer."

When considering specific types of red meats, hamburgers -- but not steak -- were linked to an increased risk of prostate cancer, especially among Hispanic men. "We speculate that these findings are a result of different levels of carcinogen accumulation found in hamburgers, given that they can attain higher internal and external temperatures faster than steak," Stern added.

Researchers also found that men with diets high in baked poultry had a lower risk of advanced prostate cancer, while consumption of pan-fried poultry was associated with increased risk. Stern noted that pan-frying, regardless of meat type, consistently led to an increased risk of prostate cancer. The same pattern was evident in Stern's previous research, which found that fish cooked at high temperatures, particularly pan-fried, increased the risk of prostate cancer.

The researchers do not know why pan-frying poses a higher risk for prostate cancer, but they suspect it is due to the formation of the DNA-damaging carcinogens -- heterocyclic amines (HCAs) -- during the cooking of red meat and poultry. HCAs are formed when sugars and amino acids are cooked at higher temperatures for longer periods of time. Other carcinogens, such as polycyclic aromatic hydrocarbons (PAHs) are formed during the grilling or smoking of meat. When fat from the meat drips on an open flame, the rising smoke leaves deposits of PAHs on the meat. There is strong experimental evidence that HCAs and PAHs contribute to certain cancers, including prostate cancer.

"The observations from this study alone are not enough to make any health recommendations, but given the few modifiable risk factors known for prostate cancer, the understanding of dietary factors and cooking methods are of high public health relevance," said Stern.

Co-authors of the study include Amit Joshi who received his Ph.D. in molecular epidemiology from the Department of Preventive Medicine at the Keck School of Medicine; Chelsea Catsburg, Juan Pablo Lewinger and Sue Ingles of USC; and CPIC's Esther John and Jocelyn Koo. The study was supported in part by the Prostate Cancer Foundation, American Cancer Society, and grant 5P30 ES07048 from the National Institute of Environmental Health Sciences and the National Cancer Institute.

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Story Source:

The above story is reprinted from materials provided by University of Southern California - Health Sciences.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.


Journal Reference:

  1. Joshi AD, Corral R, Catsburg C, Lewinger JP, Koo J, John EM, Ingles S, Stern MC. Red meat and poultry, cooking practices, genetic susceptibility and risk of prostate cancer: results from the California Collaborative Prostate Cancer Study. Carcinogenesis, Jul 20, 2012 [link]

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

Source: http://feeds.sciencedaily.com/~r/sciencedaily/top_news/top_science/~3/-r2Ur1rkBcQ/120816170404.htm

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Longest running UK comic 'The Dandy' faces closure

(AP) ? Britain's longest-running children's comic is facing closure after 75 years in print.

The publisher of "The Dandy" said Tuesday it is reviewing all of its magazine titles to meet the "challenges of the rapidly changing publishing industry."

Circulation of the weekly comic, first published in 1937 and best-known for cartoon character Desperate Dan, dropped to less than 7,500 in the second half of last year. At its peak in 1950 it sold some 2 million copies.

Scotland-based DC Thomson said it is yet to make a decision on the comic's future, but will ensure all of its characters live on in other platforms ? hinting that the comic may soon only be available online.

"There are many challenges within the industry at present, but we're excited that the digital revolution has also given us an opportunity to innovate and develop," the publisher said in a statement.

"The Dandy" first went on sale in 1937 costing 2 pence, and became so successful its publisher launched a similar comic, "The Beano," within months.

Anita O'Brien, curator of London's Cartoon Museum, said when launched "The Dandy" offered its young readers something new ? more action and more visual material than contemporary magazines.

"A lot of the publications in Britain would have been what you'd call boy's story papers ? mostly text with a few illustrations," she said. "It was new in having a lot of funny strips, it was very brash and slapstick in its comedy."

But the character fell behind the times and many news agents have not stocked it for years, O'Brien added.

Associated Press

Source: http://hosted2.ap.org/APDEFAULT/cae69a7523db45408eeb2b3a98c0c9c5/Article_2012-08-14-Britain-Oldest%20Comic/id-e97bc97de87f426d975971905d376252

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Source: http://sagefitness.blogspot.com/2012/08/new-morning-classes-starting-in-october.html

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The Hypnotic Laws 75, Self Help

Conquer Your Fears And Effortlessly Manifest Your Dreams As An Affiliate Of An Excellent Personal Development Program. Solid Sales Funnel In Place. Http://hypnoticlaws.com/affiliate-resources

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    Unforgiven (1992): Bob Leaves Big Whiskey

    Unforgiven (1992): Bob Leaves Big Whiskey

    The clip Bob leaves Big Whiskey from Unforgiven (1992) with Gene Hackman, Richard Harris Give these keys to the conductor. He can loose Bob's cuffs as soon as he's outside the county. Got my pistols? I guess you know, Bob, that if I see you again I'll just shoot in self-defense. I didn't steal your biographer! He's staying on his own account! He can go stuff himself as well, can't he?! A plague on the whole stinking lot of you! Without morals or laws! And all you whores! You got no laws and no honor! It's no wonder you all emigrated to America! They wouldn't have you in England! You're a lot of savages! You're all a bunch of bloody savages! A curse on you! Nobody's going to come after what Little Bill done to that Englishman. Delilah, can't you get them tables clean? Cover your face, somebody might hump you and you wouldn't have to clean. What do they call that face cover? A veil. Yeah. Get a veil! Rain's coming. Thank God.
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    Man on the Moon (1999): Getting Used to the New Condition

    Man on the Moon (1999): Getting Used to the New Condition

    The clip getting used to the new condition from Man on the Moon (1999) No more Kaufman stories. He's burned us too many times. A very reliable source told me, Andy Kaufman has lung cancer. Please, he's definitely not dying. Now those big white cells are attacking the cancer cells. Attacking. Attacking. I see them. I see the white cells. Attacking. Attacking. Attacking. Attacking. He's an actor. I recognize him from The In-Laws! That's true. But he's also ordained in holistic medicine. What am I supposed to do? I'm sick and I'm tryin' to get better, but everybody's lookin' at me funny. I feel like I'm being surrounded by negative energy. You're surrounded by what you create. Oh, great. Andy, you're the king of negative energy. It's gotta stop. Andy. 'Cause if these negative vibes get out, then everyone'll talk about how sick I am. And it becomes a self-fulfilling prophecy. How can I help you? I want to go back to work. You want to tour the clubs? No, no clubs. I want to reach the top. Carnegie Hall! I just want this show to build and build!
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    The clip talking to the workers from The Rebel (2006) What are you looking at? The woods. I can see that. But this place is a god damn prison. How did you end up here? Couldn't afford their "self-tax. " I'm just a servant. Everyone is subject to the law. What about laws that sanction slavery? No such law. You think people volunteered to come here? One way or the other, we will all end up on that truck. Move away! Stand up!
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Food & Drink Innovation Network ? NEW MCGUIGAN ROSE FROM ...

August 13th, 2012

The new McGuigan Classic Ros? is the latest innovation from pioneering Australian winery McGuigan Wines.

Crafted in a classic Provence style, this light, dry Wine deliberately breaks the Australian ros? mould ? which traditionally has a ripe flavour ? and has been ?created to satisfy changing British wine tastes.

Selling over 17 million cases a year in the UK, ros? is becoming a more and more popular choice with British wine drinkers.

It has been categorised as a sweet wine however, with summer sun rare in the UK, British wine drinkers are increasingly looking for more aromatic wines, that can be drunk whatever the weather.

Recognising this new trend, the winemakers at McGuigan Wines took up the challenge to create a new Australian wine that would challenge the popular conception of, and satisfy demand for a cleaner, fresher ros?.

The McGuigan Classic Ros? was produced to be a versatile easy-drinking wine that matches with a wide variety of foods from the usual, such as seafood and salad; through to more robust dishes such as pasta and Asian style food.

Neil McGuigan, Chief Winemaker said:

?With this wine we wanted to create something that wine drinkers wouldn?t expect of an Australian ros?.

?Whilst a cool glass of ros? is fantastic in the sunshine, we?ve noticed that British wine drinkers are looking for more, and are increasingly choosing a drier, more versatile style.

?We believe that this wine combines everything wine drinkers have traditionally loved about ros?, but with a perfect balance that is deliciously refreshing.?

The McGuigan Classic Ros? is available at Sainsbury?s at RRP ?7.99.

Related posts:

  1. New wines developed for UK market
  2. ?Biggest-ever? wine marketing campaign launched
  3. JUNE 30TH TASTE 100 BEST AUSTRALIAN WINES AT AUSTRALIA HOUSE
  4. PINK PIG IS TO BE LAUNCHED
  5. TREASURY WINES UNVEILS NEW BELLA VIA WINE BRAND
  6. GALLO LAUNCHES FIRST CALIFORNIAN MERLOT ROSE INTO UK
  7. ARNISTON BAY EXTENDS SPARKLING RANGE WITH ROSE
  8. NEW ROSE VARIETY OF PORT IS LAUNCHED ? CROFT PINK

Source: http://www.fdin.org.uk/2012/08/new-mcguigan-rose-from-australia/

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