Women Lifestyle See It Now

Since the 60s, smoking women has continued to grow: the proportion of smokers rose from 10 to 22% in 40 years on the 15 million smokers in USA. The women smoke more and more and earlier. The first cigarette is usually taken between 14 and 16 years. Cigarette smoke passes from the lungs to the brain within 10 seconds, carrying so much faster than would intravenous injection of illicit drugs. Smoking cigarette send some 4 000 chemicals to the body.

Tobacco and gynecological disorders

Smoking decreases the secretion of estrogen. It may therefore be responsible for menstrual disorders with irregularities and pain. There is also often a change of tone of voice, which becomes hoarse, and an increase of hairs. Menopause occurs 1 to 2 years earlier than average among smokers. Hot flashes are more intense and the risk of osteoporosis is increased. Tobacco also promotes the development of precancerous lesions of the cervix.

Tobacco and skin

Due to a lack of oxygenation of the skin, smokers are more often dull complexion and “clouded”. The cellular exchanges have slowed and the waste is not eliminated. The skin loose his radiance and elasticity. Wrinkles appear prematurely, with 10 to 20 years ahead, especially at the lips. Smoking stimulates the production of free radicals that damage the elastin and collagen.

Tobacco and pill

35% of women aged 20 to 44 years who take contraceptive smoke, increasing from 4 to 10 times the risk of cardiovascular problems. Combining a contraceptive with cigarettes is a major health hazard, especially past 35 years. Indeed, nicotine promotes deposition of fat in the blood vessels and damages arteries. The blood thickens and the risk of thrombosis, stroke and cerebral vascular accident (stroke) is accentuated. These evils are aggravated by contraceptives.

Smoking and Pregnancy

Cigarette smoking decreases by 50% female fertility: thickens the cervical mucus, preventing sperm progression, lack of estrogen reduces the quality of the uterine wall and restricts blood flow necessary for the implantation of the egg. Smoking increases by 3 the risk of miscarriage, and by 2 ectopic pregnancies and premature births. There is also stunted fetus that is not well oxygenated. Its weight is generally lower than 200 g at birth. In addition, smokers lactating produce 25% less milk than non-smokers.

Tobacco and weight

Smoking reduce the taste and smell. In addition, nicotine stimulates the nervous system that causes a cut-hunger, slows the storage of fat in adipocytes and artificially increases energy expenditure to 200 calories per day compared to non-smoker. The smokers have a weight lower than they would if they do not smoke (around 4 kg). So when you stop smoking, you just go back to your normal weight. No need to worry! However physical activity is still recommended to stabilize the weight. If you start to gain to much weight, try to eat better by cutting in the fat and salt.

It may be a good idea to consult a dietetist to help stabilize your weight while you stop smoking. Consulting a dietetist is a sure way to establish a healthy and balanced diet. Using dangerous product like laxative and purgative are dangerous and not the solution to long lasting weight loss!

The CW’s Gossip Girl tells the tales of teens in the elite world, and the nitty gritty details including sex, dtugs and underage drinking. Since its first airing, the show has received criticism for its provocative subject matter, and unrealistic portrayal of individuals. However, stars from the series had come to the show’s defense, saying that Gossip Girl does not exactly emulate reality, but rather presents a number of issues relevant to the youth today.

“I think that our show takes place at a heightened reality a little bit… I think a lot of the realism is lost in the sparkle, and it’s meant to. You need that for the entertainment and the grit,” Blake Lively, who plays Serena van der Woodsen on Gossip Girl, said on The View. “But this stuff does happen and it’s good that we get to address these issues. It does open the door for conversations for parents to have with their children.”

Penn Badgley, who plays Dan Humphrey on the teen series also expressed his sentiments about the show, saying that the characters who are most engaged in the crazy elite lifestyle are the ones who have “the most shattered family lives.”

“You see the repercussions of it at such a young age,” Badgley said. “There’s an element of it that’s very realistic… It is heightened reality because it is television, but they did get it from somewhere.”

Despite the criticism from the older crowd of viewers, Gossip Girl, which is based on the book of the same name written by Cecily von Ziegesar, has become a big hit among teens. In fact, it is one of the most downloaded programs on iTunes. Moreover, the show’s success came as a surprise to Blake Lively, who isn’t used to all the publicity.

“It’s a little strange to walk down the street and see the big billboards” the young actress said.

Gossip Girl airs on Wednesdays, 9/8c on The CW

Regulatory Affairs Outsourcing

Regulatory Affairs Unit in a pharmaceutical company is a vital unit that drives the R & D efforts of the company to the market successfully. Today a Regulatory Affairs department is a dynamic business unit which works with a focus to get products to the market with a commercially viable label in the least possible time and expenses.

Today the world has become a global village and many companies are in a race to place many new products in the world markets to gain market share and increase earnings. In such a scenario a small delay in gaining market access means huge loss in terms of market share and revenue generated. The key to success for pharmaceutical companies lies in obtaining timely marketing approval from regulators.
So to obtain timely marketing approval companies can either strengthen then regulatory department or outsource the same to regulatory affairs consulting firm.

With changing global regulatory norms, outsourcing regulatory affairs work seems a more beneficial option both in terms of time and money. Maintaining a large regulatory affairs department can be very expensive and scope of knowledge can be limited to certain aspects. On the other hand a regulatory affairs consultant keeps on updating himself with the current regulation and has vital experience in the field to expedite the approval process.

This article further explores the services provided by regulatory affairs professional and the key points for proper selection.

There are many regulatory affairs consulting firm providing services both at a large scale and small scale. Large scale service provider’s posses large ranges of expertise under one roof, operate on a global basis, some even have local presences in different countries. While small regulatory firms specialize in one or the other aspect of regulatory affairs, for e.g. compiling dossiers, Analysis, agency contacts etc.

Well established regulatory firms can provide service in the following ways
•   Compiling large regulatory application for submission in different countries
•   Expertise Knowledge regulatory and scientific knowledge
•   Expertise knowledge and support in terms of local regulatory authority
•   Expert solutions to FDA queries
•   Access to Scientific and technical resources
•   Formulation and implementation of regulatory strategies on a global level

A regulatory firm can sure accelerate the submission process, but this won’t happen unless there is active participation of the customer (party hiring the regulatory firm).
Once it is established the service offered by regulatory affairs professional can help company save both time and money, proper selection of regulatory professional is very important. This article will explore some of the key points for selecting a regulatory affairs consultant

Experience: Experience in pharmaceutical industry particularly in drug development is an essential for pharmaceutical regulatory consultants. Consultants should have experience in preparation and submission of regulatory documents. A consultant working actively in this field for 5 -10 years will have extensive knowledge on getting approval for various drugs, he will be able to formulate regulatory strategies and implement them. His professional references, documents prepared by him, approvals obtained by him, articles published by him can be used to evaluate his experience.

Confidentiality: A Confidentiality agreement has to be in place to protect your company’s proprietary knowledge. A consultant’s confidentiality can be evaluated by requesting previous studies and information shared can be used to judge the same.

Staff: A company must have adequate staff to serve ongoing projects without delay. The staff must be highly skilled and trained to carry out regulatory work. Staffing capability can be judged by visiting the consultant’s office, professional associations, website information and office locations.

Collaborations: The Company must have access to key technical and scientific
resources at their disposal for timely completion which can be achieve by having in house facility or collaboration with other service providers.

System: Company should have in place standard system to carry out the work effectively. Initial communication with the company will give an impression of how far the company is organized and follows a standard system.

Technology: Technology has become a key part for success and timely submission today. With the introduction of eCTD it has become important for companies to integrate technology in their companies. Website of the company can be an example of adoption of technology.

There are many more criteria which can be used to evaluate and select proper regulatory affairs consultant but this article is limited to the above mentioned criteria only.

Regulatory affairs outsourcing is on a growth worldwide, many large and small companies have adopted this strategy to get a timely approval. Even multinational firms are outsourcing their regulatory work to lessen the pressure on their in house team or to support the same.