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Advanced Surface Ablation

31. července 2012 v 3:50 |  essay
patients with corneal thickness below a certain minimum, performing LASIK would be unwise, because the "foundation" may not go back to its original stability. Our colleagues from around the world, agree on when not to do LASIK, like when the cornea is very steep or very flat. In those cases we feel strongly that advanced surface ablation or (PRK) would be the preferred procedure.
This information has been shared at seminars, meetings and now, even on webmail. This procedure involves sculpting the cornea at the surface. This is done by removing the epithelium, (the film-like protective outer layer of the cornea) using a special instrument called Amoils epithelial scrubber. The underlying Bowman's membrane (the micro-thin second tissue layer of the cornea that lies just below the epithelium, or outer layer) is exposed.
Laser pulses with variable spot size and variable repetition rate are applied in a blended large zone. Mitomycin C may be applied if indicated. Chilled BSS is used to cool the cornea. A bandage soft contact lens, is placed afterwards to maintain comfort in the eye. Oral vitamin C along with steroidal and non-steroidal, anti-inflammatory drops are prescribed. Patients are asked to wear dark U.V. protective glasses.
Although recovery is usually longer than with LASIK, patients are very happy with their vision. In the early days, PRK was very painful and vision was not good. With dvanced surface ablation there is minimal pain and most patients resume work in 3-4 days.
Dr. Khanna is an Internationally recognized top LASIK and refractive vision care specialist. Dr. Khanna performs the safest and most technologically advanced methods of refractive laser surgery, including the ultra precise WavePrint, 3D ActiveTrak and Variable Spot Scanning used to correct near-sightedness, far-sightedness and astigmatisms.
 

Marketing Authorisation - Medicinal Products

31. července 2012 v 3:49 |  essay
keting Authorisation: Medicinal Products The case of R (on the application of Merck Sharp and Dohme Ltd) v Licensing Authority [2005], concerned the application for marketing authorisation for a generic product which was based on Product C (see below).
The claimant had marketing authorisations for three medicinal products used in the treatment of osteoporosis and three generic companies sought marketing authorisation for Product C.
Product A - was authorised by the European Community in 1993;
Product B - was authorised in 2000
Product C - was a generic product based on Product B (a copy of Product B).
When a company applies for marketing authorisation for a product, it is a requirement under the European Parliament and Council Directive (EC) 2001/83 (the "Directive"), to supply a full set of data in order to show the safety and efficacy of the product.
There are instances under the Directive when an applicant can simply rely on data submitted in respect of a previously authorised product. For instance, the applicant could refer to data already submitted in respect of a product with marketing authorisation, where the applicant is seeking authorisation for a product 'essentially similar' to a product holding a marketing authorisation for ten years (as per the United Kingdom and pursuant to art 10(i)(a)(iii) of the Directive).
In seeking marketing authorisation for Product C, the generic companies relied on data submitted in relation to Product A and Product B. However, although Product A and Product B contained the same active ingredient, they were not 'essentially similar' within the meaning of the Directive. This meant that they differed in respect of their posology (the schedule of dosage). The defendant accepted that the generic companies did not have to provide any further data but the claimant argued that such an approach was unlawful and in breach of the Directive. The claimant made a reference to the European Court of Justice ("Court of Justice").
The claimant contended that the issue was as yet unresolved by the rules laid down in previous decisions of the ECJ. In particular, it was argued, that there had been no cases where a difference in posology had been the subject of a decision.
The application was dismissed. The ECJ held that:
The principles laid down by the ECJ in earlier decisions were clearly applicable in this case and there was no uncertainty;
Although it was true that a change in posology had not previously been the subject of a decision, it was for the ECJ to interpret the EC Treaty and the relevant principles by which it was to be interpreted, and for the domestic court to apply those principles to the particular case. No new principles arose in the instant case.
If you require further information contact us.
Email: enquiries@rtcoopers.com
RT COOPERS, 2005. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances.
Rosanna Cooper is a partner in RT Coopers Solicitors a full service law firm in London. The firm specialises in patents, trade marks, copyright, designs, technology transfer, biotechnology and pharmaceutical law. The firm has a flexible approach to fees and provides the highest quality legal advice.

A Goodbye Kiss

31. července 2012 v 3:48 |  essay
The Board Meeting had come to an end. Bob starred to stand up and jostled the table, spilling his coffee over his notes. "How embarrassing. I am getting so clumsy in my old age."
Everyone had a good laugh, and soon we were all telling stories of our most embarrassing moments. It came around to Frank who sat quietly listening to the others. Someone said," Come on, Frank. Tell us your most embarrassing moment."
Frank began," I grew up in San Pedro. My Dad was a fisherman, and he loved the sea. He had his own boat, but it was hard making a living on the sea. He worked hard and would stay out until he caught enough to feed he family. Not just enough for our family, but also for his Mom and Dad and the other kids that were still and home." He looked at us and said," I wish you could have met my Dad. He was a big man, and he was strong from pulling the nets and fighting the seas for his catch. When you got close to him, he smelled the ocean."
Frank's voice dropped a bit." When the weather was bad he would drive me to school. He would pull right up in front, and it seemed like everybody would be standing around and watching. Then he would lean over and give me a big kiss on the cheek and tell me to be a good boy. It was so embarrassing for me. Here I was twelve years old, and my Dad would lean over and kiss me good-bye!"
He paused and then went on," I remember the day I thought I was too old for a good-bye kiss. When we got the school and came to a stop, he had his usual big smile. He started to lean toward me, but I put my hand up and said,' No, Dad.' It was the first time I had ever talked to him that way, and he had this surprised looked on his face.
I said,' Dad, I'm too old for a good-bye kiss. I'm too old for any kind of kiss.' My Dad looked at me for the longest tine, and his eyes started to tear up. I had never seen him cry. He turned and looked our the windshield.' You're right,' he said.' You are a big boy…… a man. I won't kiss you anymore.'"
For the moment, Frank got a funny look on his face, and the tears began to well up in his eyes. "It wasn't long after that when my Dad went to sea and never came back."
I looked at Frank and saw that tears were running down his cheeks. Frank spoke again." Guys, you don't know what I woud give to have my Dad give me just one more kiss on the cheek…… to feel his rough old face…… to smell the ocean on him…… to feel his arm around my neck. I wish I had been a man then. If I had been a man, I would been a man, I would never have told my Dad I was too old for a good-bye kiss."

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