Global Healthcare Stakeholders to Gather in Austin for Regulatory Convergence


Rockville, MD, USA (PRWEB) September 11, 2014

The practitioners of a profession that has a profound impact on healthcare around the world, but whose work is not well understood by the general public will gather in Austin, TX, this month when the Regulatory Affairs Professionals Society (RAPS) holds its annual Regulatory Convergence at the Austin Convention Center from 27 September through 1 October. 2014 RAPS: The Regulatory Convergence will bring together healthcare product regulators from agencies including US Food and Drug Administration (FDA), scientists, innovators, and representatives from small, mid-sized and large multinational pharmaceutical, biotechnology and medical device companies.

Every day, consumers and patients around the world rely on healthcare products they count on to be safe and effective. It may not be well known or understood, but the regulatory professionincluding regulators, industry professionals, researchers and othersplays a critical role in ensuring the safety and efficacy of those products, said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. The Regulatory Convergence is where regulatory stakeholders from different areas and different parts of the world come to learn, network and share ideas. Beyond that, its where the regulatory community comes together to drive regulatory excellence at the individual, organizational and global levels.

While the profession gathers in Austin, it presents an opportunity for healthcare journalists and bloggers to get insight into how medical products and technology are regulated, get the latest regulatory updates and hear directly from the people involved. The 2,000 expected attendees include those responsible for safeguarding public health and those who ensure the products their companies make meet regulatory standards, as well as industry vendors and exhibitors.

Program tracks include Biologics and Biotechnology, Health-Related Foods, Pharmaceuticals, Medical Devices and In Vitro Diagnostics, Regulatory Business and the roundtable-discussion Situation Room sessions. For the full schedule of workshops and sessions, visit http://connect.raps.org/2014raps/schedule, or download the conference program. Follow conference updates and conversations on Twitter using the #2014RAPS hashtag.

Topics to be covered in the more than 70 sessions by 250 speakers include:

Regulatory challenges of bringing a mobile medical app to market
Medical device cybersecurity
Social media rules for the pharmaceutical and other closely regulated industries
3D printing and regulatory implications
Regulation of human cells and tissues
Clinical trials and transparency
Healthcare regulation in emerging markets
International regulatory collaboration and harmonization

See also: 10 Sessions We Can’t Wait to Attend at 2014 RAPS

Speakers will include more than 50 officials from approximately 20 health authorities. Top officials from FDA who will be in Austin include: Ann Ferriter, director, division of risk management operations, Office of Compliance, Center For Devices And Radiological Health (CDRH); Sabine Haubenreisser, MSc, PhD, European Medicines Agency liaison official; Reynaldo (Ricky) R. Rodriguez, Jr., district director, Dallas District; Leah Christl, PhD, associate director for therapeutic biologics, OND Therapeutic Biologics and Biosimilars Team, Center for Drug Evaluation and Research (CDER); and Alberto Gutierrez, PhD, director, office of in vitro diagnostics, CDRH.

Several FDA officials will participate virtually, including CDER Director Janet Woodcock, MD; Kimberly Trautman, associate director, internal affairs, Office of the Center Director, CDRH; and Robert “Skip” Nelson, MD, PhD, deputy director and senior pediatric ethicist, Office of Pediatric Therapeutics.

Other international health authority speakers will include officials from the European Medicines Agency; the European Commission; the China Food and Drug Administration; Japans Pharmaceuticals and Medical Devices Agency, and Ministry of Health, Labour and Welfare; the Health Science Authority of Singapore; Health Canada; the Food Safety and Standards Authority of India; the Taiwan Food and Drug Administration; and the ministries of health of Malaysia, Indonesia, Singapore and Brazil.

Conference sessions will begin on Monday, 29 September with a keynote presentation on the continuing evolution in global healthcare and changing consumer behaviors and expectations from David Bosshart, PhD, CEO of the Switzerland-based Gottlieb Duttweiler Institute.

During the closing plenary on Wednesday, 1 October, expert panelists will tackle a similar topic from a different angle. Martha Brumfield, PhD, from the Critical Path Institute; Mike Ward, Health Canada; Murray Lumpkin, MD, MSc, Bill & Melinda Gates Foundation; and John Lim, Singapore Ministry of Health and the Duke-National University of Singapore Graduate Medical School will examine the complexity of delivering healthcare products to consumers around the world in a safe and cost-effective manner while dealing with shifting regulatory paradigms, regulatory science and regulatory capacity.

For those seeking more in-depth instruction on specific subjects, one- and two-day pre-conference workshops on 27 and 28 September will cover essentials of regulatory affairs and regulatory strategy for specific regions and product categories.

Reporters, bloggers and other members of the media who wish to cover all or part of 2014 RAPS should contact Zachary Brousseau, senior manager, communications for RAPS. On-site registration also will be available for media with valid press credentials or a letter from an assigning editor on company letterhead.

About RAPS

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Shanghai and Singapore, and chapters and affiliates worldwide. RAPS.org

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More Food Press Releases

Got Geese? Start Controlling Them Now


Chicago, IL (PRWEB) September 02, 2014

The Canada goose is one of the most common North American pest birds, known for stubbornly returning to the same areas year after year. Populations of year-round resident geese have been exploding in recent years, while migratory birds add to their numbers seasonally.

In the United States, September marks the return of birds from Canada joining the resident flocks, and the problem gets worse as winter goes on. For this reason, Bird-X pest control experts recommend setting up goose prevention devices now when resident geese are no longer attached to their nests, and before new geese move in and get too comfortable. The key is prevention as early on as possible.

Canada geese are complex creatures with extremely sharp sensory capabilities in both hearing and vision. They follow instinctive cyclical behaviors throughout the year. Knowledge of these seasonal variations is essential to implementing successful strategies for long-term Canada goose control.

Because Canada geese are creatures of habit, once a habitat has been chosen they are known for returning year after year. They select areas that meet their needs; grassy areas and especially those with bodies of water, such as golf courses, corporate grounds, and hospital grounds provide these birds with everything they need. Grass itself serves as a nutritious food source, which is why these birds are so often found on lawns. By using a liquid aversion product such as Bird Stop to cover the lawns, birds find the grass no longer appetizing and will seek out grassy areas that taste better. This is the same product used by farmers to protect fruit; it is harmless and commonly used.

Geese also respond to sound technology, but recorded sounds need to be specific to their species (most bird callers are not made for geese). Dr. Philip Whitford, Ph.D., who has studied Canada geese for over 30 years, recorded the only documented natural recording of a Canada goose alarm call. Combined with the Canada goose alert call, these sounds were used to create the Bird-X GooseBuster. Tested by Dr. Whitford over many years, this is the most effective, continuously relied upon goose control product available on the market today.

Visual decoys can also be beneficial, especially when combined with the tactics mentioned above (by creating a multi-sensory attack and making an area as unwelcoming as possible, geese are far less likely to get very comfortable). When placed on property early in the season, freshly returning geese will quickly see that predators have moved into their territory, think this area is not safe, and will move on.

General bird control means the clean-up of any bird mess (feather, droppings, and any remaining nests), as birds look for these markings to recognize safe territory. This is also just good housekeeping, and any responsible building owner, facility manager, or landscaper should be doing this anyway, since bird feces can carry disease, fungus, and other potentially dangerous materials. Geese themselves can be dangerous to humans as they are prone to attack, especially if they are allowed to nest. Furthermore, the Migratory Bird Treaty Act of 1918 prevents the removal of geese when they are actively nesting until the goslings are old enough to move on safely; therefore prevention is in anyones best interest.

By installing goose control methods now, the risk of a larger goose problem later is greatly reduced. Once nesting starts in later winter and early spring, geese are much more challenging to move; the best opportunity to start a program is now in late summer and early Fall, when adults have recovered from their molt and goslings are capable of leaving.

Bird-X, Inc. is the leading international brand of bird control products since 1964, and is dedicated to protecting human health, wildlife and the environment in which we all live. The Chicago-based company manufactures a complete line of unique pest control products with an unmatched focus on quality, efficacy, and customer service.







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Community Rallies Behind Annual Food Festival

Atlanta, GA (PRWEB) September 04, 2014

In its seventh year of gastronomic greatness and backed by popular demand, the Taste of Chamblee food and music festival will yet again dawn the chefs hat and return to the heart of Chamblee (Peachtree and Broad street), October 4, 2014 from noon to 7:00pm, to serve up some of the more culturally diverse cuisine of the Atlanta food festival scene.

The annual main street festival, presented by Discover DeKalb Convention & Visitors Bureau, proves there is no I in grub, with this years line-up already including Platinum-selling Georgia Music Hall of Famer and multiple Billboard chart top-10 recording artist, Atlanta Rhythm Section, as headlining musical act on the Discover Dekalb main stage, over 20 of Chamblees best kept secrets and main street favorites. Progress has been made to include not only the restaurants housed on Chamblees Antique Row, but also the colorful culinary landscape of Buford Highway and surrounding areas.

Hosting the festival for an expected 5,000 attendees is the newly minted Chamblee Chamber of Commerce, with proceeds benefiting the Chamblee-based nonprofit, Georgia Lions Lighthouse Foundation, that serves uninsured and underinsured Georgians across the state by providing access to the vision and hearing care needed to live healthy and productive lives.

Join your fellow Atlantans in ushering in the new season with good times, good people and even better food. The Taste of Chamblee not only benefits your stomach, it also supports our local businesses, artists, restaurants, and the Georgia Lions Lighthouse Foundation, which the whole family can enjoy! Questions? Suggestions? Restaurant nominations? Want to be a vendor? Food? For a full list of local participating restaurants and sponsors, please visit http://www.TasteofChamblee.net #TOC14







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FUNG BROS FOOD: Filipino Food w/ @AJRafael

Buy the BOBALIFE, ASIANS EAT & T.O.Y.S shirt: http://shop.akufuncture.com Use: FUNGBROTHERS for 10% off! LIKE: http://www.facebook.com/thefungbros FOLLOW: http://www.twitter.com/FungBros…

When your food fights back! Post to Facebook: http://on.fb.me/1n4Gf3Q Like BuzzFeedVideo on Facebook: http://on.fb.me/1ilcE7k Post to Twitter: http://bit.ly/…
Video Rating: 4 / 5

Restaurant Review Site Tabelog Announces the Winners of the San Francisco Bay Area Summer 2014 Tabelog Restaurants Awards


San Francisco, CA (PRWEB) August 20, 2014

Tabelog, Inc. has announced the winners of its summer 2014 Tabelog Restaurant Awards, hosted by the companys restaurant review site. The top food bloggers from the San Francisco Bay Area came together as a judges panel to select the top restaurants in five fun and informative categories. The winners are awarded with an exclusive Tabelog Restaurant Award for their restaurant along with all of the exposure associated with hundreds of blogs and thousands of followers.

The awards are hosted by restaurant review site Tabelog.us which is the US version of the 50 million member website in Japan. Launched April 2013, Tabelog aims to bring high quality reviews of restaurants in US to food lovers, enlisting the help of top food bloggers, critics, and industry experts.

From a business lunch to a date night, Tabelog is the place to learn about restaurants in the San Francisco Bay Area. A typical restaurant review on Tabelog has multiple paragraphs of information and photos of the decor, menus, and of course the food. Food experts review everything from their favorite dish and how it was prepared to what desserts they recommend. You can also learn what to expect of restaurants, how to dress and sometimes even the history of the restaurants and the chef. If you want to impress at dinner, these reviews are second only to eating there itself.

Tabelog calculates restaurant rankings using an algorithm based on both user reviews and point-based ratings. This allows its users to find restaurants rated highest by local food experts by area or type of cuisine.

Here are the winners of the Tabelog Restaurant Awards:

Tabelog Restaurant Awards San Francisco Bay Area Summer 2014 Results

Best Brunch

New Research Shows How Parents Can Save Over $400 Per Child Per School Year with Reusable, Waste-Free Lunches

Plantation, FL (PRWEB) August 13, 2014

Wild Mint, an eco-friendly, healthy living company, has released a Lunch Savers guide to help inform parents on ways they can save money, their health, and the environment with reusable, waste-free lunches this back to school season. The guide contains research about the differences between a disposable lunch, containing materials such as plastic baggies, paper napkins and disposable bottles, and a reusable, waste-free lunch, where everything can be eaten, reused, recycled or composted.

One of their most striking findings is that parents can save over $ 400 per child per school year by packing a reusable, waste-free lunch over a disposable one. When it comes to lunch gear, choosing reusable contents can help parents save money over time by only having to purchase the products once instead of the purchase-then-toss cycle that results from disposable gear. Monetary savings can also come from the food packed in a reusable lunch. For example, parents can save money by purchasing a large box of crackers instead of individual packs, a jar of juice instead of juice boxes, and fresh cut fruit instead of fruit cups.

The guide also details numerous health and environmental benefits for families who forgo disposable lunches for healthier, reusable ones:

Health Benefits

Jeffrey D. DeCarlo, P.A., Alerts Consumers About Bleeding Risks Linked to Xarelto Blood Thinner Drug

Miami, FL (PRWEB) August 11, 2014

Drug injury attorney Jeffrey D. DeCarlo of Jeffrey D. DeCarlo, P.A., has learned that Xarelto lawsuits already have been filed alleging the blood-thinning medication caused uncontrolled bleeding, according to a Reuters report on June 14.

Reuters reports lawsuits have been filed in the United States, as of June 14, 2014. According to court records, one lawsuit was filed February 24 on behalf of Virginia Stuntebeck, a Kentucky woman who alleged she suffered severe internal bleeding related to the use of Xarelto.

Court records state that Stuntebecks suit against Janssen Research & Development and Bayer Corp. alleges she suffered severe bleeding requiring hospitalization after being prescribed Xarelto in July 2012 to treat an irregular heartbeat. (Stuntebeck v. Janssen Research & Development LLC et al, Case Number 140201754; Court: Philadelphia Court of Common Pleas).

Another recent lawsuit alleges Nancy Packards husband, William N. Packard of Florida, died because of uncontrollable bleeding after being exposed to Xarelto (Nancy Packard v. Janssen Research & Development LLC et al; Case Number 9:14cv80831; U.S. District Court for the Southern District of Florida).

According to a U.S. Food and Drug Administration (FDA) medication guide, Xarelto can cause potentially serious bleeding and may lead to death.

The FDA recommends that Xarelto users who have experienced any of the following side effects call their doctor or get immediate medical help if they develop any of the signs or symptoms of bleeding. Some of the signs include reoccurring nose bleeds; unusual bleeding from the gums; heavier-than-normal menstrual bleeding; and red, pink or brown urine, among other symptoms.

DeCarlo, who has handled complex drug injury claims, said people who have experienced adverse side effects of any medication should consult with an attorney to learn about their rights.

A serious injury or a fatality due to exposure to a drug can lead to serious financial hardship, emotional distress and other losses, DeCarlo said. Attorneys can help people pursue the compensation they need so they can get on with their lives.

Source

The Reuters article cited is Bayer faces law suits in United States over Xarelto: paper.

About Jeffrey D. DeCarlo, P.A.

Attorney Jeffrey D. DeCarlo is a nationally recognized pharmaceutical injury lawyer who has protected the rights of injury victims for over 15 years. His office is in Miami, Fla., but he serves clients throughout the State of Florida and the United States. Attorney Jeffrey D. DeCarlo is a member of both the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum, reserved for a small percentage of attorneys who have secured multi-million dollar verdicts and settlements. In addition to handling dangerous drug claims, attorney Jeffrey D. DeCarlo accepts cases involving medical malpractice, defective medical devices, car accidents and catastrophic personal injury.

Jeffrey D. DeCarlo, P.A.

4500 Biscayne Blvd #201

Miami, FL 33137

(305) 572-0065

http://www.decarlolaw.com







Root Vegetables & Winter Fruits

Have you ever been wandering through your local farmers market or produce area of your super market and see those bizarre looking root vegetables and wonder what the heck they are and how do you eat them?

Root vegetables were a very significant staple throughout the colder months during a time when lettuces and zucchini were not available in months of December, January and February. Thankfully that time has passed and we are able to enjoy these lovely treats with some leafy greens, crisp peppers or squashes.

We decided that there are too many amazing root vegetables and fall fruits that do not get enough credit and should go unnoticed or unused no longer. Below you will find a quick guide to some of our favorites over here at Epic. We hope that at the end of this you are feeling a lot less intimidated about the crazy looking fruits and vegetables and that a whole new world of produce is opened up to you.

Some of our fall favorites that you can find on our menus are Kumquats, Quince, Salsify and Celeriac.
Let’s start with Kumquats; these tiny little orange fruits are both sweet and sour. The skin is edible and is actually where all of the sweetness comes from. You can chop and mince these with some parsley, capers and horseradish to make an impressive relish or muddled with Cachaca and sugar to make a Caipirinha.

Quince is a misunderstood fruit. It is inedible raw but when cooked slowly over a low heat for a few hours they are suddenly bursting with flavor. Quince is a great addition to a traditional apple pie or added to bread pudding for a delicious twist on an old favorite.

Salsify may seem weird but is very tasty. This member of the sunflower family is called the “oyster root” because the flavor is vaguely reminiscent of oysters when cooked. You can boil, steam, cream or mash salsify. Once it is cooked it has the texture of an artichoke and some say the taste is similar.

Celeriac is very flavorful once roasted. It has a sweet and somewhat astringent flavor. When cleaning celeriac be sure to get all of the “skin” off as it becomes quite bitter. It oxidizes quickly so it needs to be dropped in a mixture of water and lemon. Celeriac when roasted makes a silky smooth, delicious soup.

We hope this clears up some of the myth surrounding these root vegetables and fall fruits. Happy cooking!

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Making Bread at Home

Good evening Epic friends & family. It has been awhile since our last post and we thought what better way to get back in the swing of things than with some inside tips on making bread at home.

Here at Epic we truly are a family that likes to get everyone involved with what we do. So I asked one of our talented Chefs, Justin Belluomini, to help me with this. After all who better to ask than the gent that makes the bread here at Epic for our new & delicious lunch menu.

So first we will talk about the ingredients used in all bread making. It is as simple as flour, water, salt & yeast. Yes, there are other ingredients used in some breads but these four truly are the heart of all bread.

I know that the task of making bread can seem daunting, choosing the yeast, the flower and making sure you know how to work with all of the ingredients separately and together. Instant or active-dry- there is no appreciative difference other than instant is more convenient. When choosing flour be sure to select a bread flour to get the optimal results but if you don’t have bread flour then go ahead and use AP flour, just be sure to check your measurements because you will need more flour. This is also true depending on what salt you choose. Kosher salt you will need more, table salt you will need less. If you have a handy scale it is best to weigh everything out.

All breads are made the same way:
First, the ingredients are mixed together, then the bread is kneaded until the gluten is sufficiently developed, the bread is then allowed to rise for a period of time (this is known as bulk fermentation and is where most of the flavor is developed), the bread is then shaped into loaves or rolls and allowed to rise again (this is known as proofing)and then the bread is baked and cooled.
Here is a link to a video on shaping:
title=”Shaping bread”>www.youtube.com/watch?v=TPL2J8OZ&feature=related.

After the bread is baked it needs to cool completely before being cut, otherwise they will come out gummy and less flavorful.

Batch Risen Dough is designed to be made in a large batch, risen and refrigerated for up to a week. When you are feeling like some home-made bread simply snip off 14-16 ounces, shape it and bake it. the bread’s flavor will develop over the next several days and become more intense and even take on some sourness.

Below is our basic recipe for an Italian Batch Risen Dough.
725 grams of 90 degree water
14 grams of instant yeast
25 grams of table salt
925 grams of all-purpose (AP) flour, we recommend King Arthur

*Place water into an 8 quart container & mix the yeast until dissolved, then add salt and immediately add flour, stir with wooden spoon until fully incorporated and let rise at room temperature for about 2 hours covered with a floured with a towel (not terry cloth) or parchment paper sprayed with oil, until it has slightly more than doubled in volume. Refrigerate dough for up to one week or minimum of 2 hours. When you are ready for that home-baked goodness, sprinkle flour across the entire surface of the dough and on your hand (to prevent dough from sticking), pull out around 14-18 ounces of dough. Loosely shape this into a ball and allow it to proof on parchment paper at room temperature for up to 90 minutes. Bake in a 450 degree oven for 30-35 minutes or until the internal temperature is 205 degrees (digital thermometer is preferred.) Let cool completely and enjoy!!

We hope you all have a wonderful & Happy Thanksgiving!!!

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July Fourth

I hope everyone is excited about the upcoming holiday. I know I am. We will be hosting a special happy hour BBQ on our fabulous patio. Also hosting will be Anchor Brewing and Skyy Vodka.
We will be offering a special BBQ menu including first of the season heirloom tomatoes with hand pulled mozzarella, pork shoulder and Schmitz Ranch brisket, rotisserie chicken, baked beans from the wood oven, potato salad, corn on the cob (probably with BACON BUTTER…a preview of High on the Hog)and ice cream cones. All of this with an Anchor Liberty Ale or Skyy vodka cocktail for $35 plus tax and gratuity. There maybe, just maybe (well, most likely will be)some specials on Drakes Bay Oysters as well.
I am super excited. Give us a call and let us know you are coming. It is gonna be a swell time!!
-ben

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Kitchen of Champions

saint vincent de paul of oakland

Celebrating graduation with a slice at Mission Pie

Over my ‘weekend’ I volunteered at the St. Vincent DePaul Society Kitchen of Champions in West Oakland, California. The students were a blast to work with and I am so happy to be a part of their learning experience.
Epic Roasthouse donated all of the flour and butter that we used in the recipes. My wife, Karoline Boehm-Goodnick, general manager at Mission Pie, was with me as well.
I would like to encourage all of you to check out the Kitchen of Champions webpage and help in any way you can. My friend Diana Petes is the Culinary Services Coordinator and can help with any questions you may have.
-ben

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High On The Hog

Pork and Pinot is back. California wineries specializing in Pinot Noir, a western theme (including appropriate music) and lots of pig.
Our annual celebration is back this year on Saturday, September tenth. I’m not going to provide you with lots of details right now (I like suspense) but call 415-369-9955 for more information and to make your reservation.
I will give you a couple food teasers: corn with bacon butter, something roasted on a spit, lots of pulled pork, and plenty of house-made and artisian charcuterie.
We hope to see you there,
-ben

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Wood Burning Brick Oven

As many of you know the soul of our kitchen is a wood burning brick oven. It is made of twenty-two thousand pounds of sand, brick and stone. We burn up to three cords of almond and walnut wood per month.

Many restaurants have wood ovens. We are different because we use ours so much. It is not just a place for pizzas and such. It provides us with a hot and smokey spot to cook everything from giant ribeye steak to Mediterranean sea bass to baby carrots. You can taste the smoke.

Maintaining a live fire for 18 hours a day is a challenge for our cooks and one that teaches us all so much about the act of really cooking. I hope that you appreciate what our oven means to us. Stop bye and peer in sometime.

-ben

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Mothers Day Brunch

First of all thanks to everyone who made Easter brunch at Epic great! If you are looking for a place in San Francisco to celebrate with your mom, Epic is the spot. We will be offering a prix fixe 3 course brunch from 10am to 3pm on Mother’s day and would love to see all of you here.

-ben

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