Events

We constantly update this page with the news and events to keep you posted as to what steps we have taken to better serve our clients.
Feb 26, 2017
EASY GLOBAL TRAINING just released a new Online Course on Good documentation Guidelines (General Chapter <1029> USP).

Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 1-hour On-Demand Webinar covers the newly published USP General Chapter <1029> “Good Documentation Guidelines”. To view a 5 minute Teaser of this online webinar Click Here.

Feb 25, 2017
EASY GLOBAL TRAINING just released a new Online Course on Good documentation Practices (GDP) that applies to anybody who deals with documents in any field in any country.

Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 100 minute On-Demand Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations. To view a 5 minute Teaser of this online webinar Click Here.

Feb 24, 2017
EASY GLOBAL TRAINING launched a new website that is highly easy to use and well integrated with social media to optimize the communication of its audience.

A website that is easy to browse, well-organized and not too busy is an advantage to any of our potential browsers. This will save you time and yet guarantees that you will find what you are looking for in our site. We are constantly asking for feedback in anything we do in all aspects of the business and we listen to what you communicate to us. Your opinion is very important to us and we perform constant updates in our website, in our inventory of products available and in the way we do business based on your feedback. So, please keep writing to us and see that it is reflected on what we do and how we deliver our services to best serve you in the direction you desire.

Jan 02, 2017
EASY GLOBAL TRAINING Renewed the Agreement to Provide Medical Affairs Consulting Services for sBLA Filing of KEYTRUDA® (pembrolizumab) with FDA.

KEYTRUDA® (pembrolizumab) is a prescription medication that is used to treat Advanced Melanoma, Non-Small Cell Lung Cancer (NSCLC), and Head & Neck Squamous Cell Cancer (HNSCC) through activating body’s immune system. However, this drug can potentially cause your immune system to attack normal body tissue and organs, which can at times become serious or even life-threatening. If this self-attack happens, certain symptoms may appear, including:

  • Lung problems specifically pneumonia;intestinal problems specifically colitis;
  • Liver problems specifically hepatitis;
  • Hormone gland issues specifically in the thyroid, pituitary, adrenal glands, and pancreas;
  • Kidney problems specifically nephritis or kidney failure; or
  • Problems in other organs (eyesight changes, severe muscle or joint pains, severe muscle weakness, anemia, and rash)

You need to immediately call your doctor in case of any of these symptoms. The clinical trials are still ongoing. For more information and to get updates about this drug, please follow the manufacturer’e news at https://www.keytruda.com/information-about-keytruda/https://www.keytruda.com/information-about-keytruda/

Aug 22, 2016
EASY GLOBAL TRAINING Entered an Agreement to Provide Medical Affairs Consulting Services for Clinical Evaluation Review of MOUNTAINEER® Laminoplasty System with EMA.

The MOUNTAINEER Laminoplasty System is an implant system that consists of screws and various sizes of plates to address the needs of the surgeon and patient as necessary. Per its Information For Use document (IFU), “the MOUNTAINEER Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures.” “The MOUNTAINEER Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion or impinging the spinal cord.” “Laminoplasties are done to treat the following conditions (Pohl, 2015; O’Brien, 1996; Yonenobu and Oda, 2003):

  • Ossification of the posterior longitudinal ligament (OPLL) over multiple levels with maintained cervical lordosis
  • Congenital canal stenosis with maintained cervical lordosis
  • Multilevel cervical spondylosis with maintained cervical lordosis
  • Posterior compression from ligamentous hypertrophy with maintained cervical lordosis.”
Apr 04, 2016
EASY GLOBAL TRAINING Entered a Joint Consulting Alliance Agreement with Neometrix Consulting Inc. in Canada.

With the growing trends of competitiveness, one of the goals of us at EASY GLOBAL TRAINING is to collaborate with entities that strengthen our presence and branding in the industry. We are looking for consultancy firms in the areas of regulatory affairs, quality compliance, and medical affairs at the global level to increase our presence to be able to better serve our customers around the globe. For the extended list of our services in each of these three consulting areas, please visit “About Us” page on our website. Following this strategy, we just entered a joint consulting alliance agreement with Neometrix Consulting Inc. Based in Toronto, Canada to further strengthen our regulatory service coverage around the globe. We are continually looking for well known companies in the area of regulatory affairs, quality compliance, and medical affairs with global coverage to form strategic collaborations in order to expand on the outreach and quality of the services we can provide to our customers at the global level.

Mar 27, 2016
Dr. Afsaneh Motamed Khorasani Was Invited to Speak on “The Utility of DR-70, a Novel Blood Biomarker, in the Early Detection of Many Types of Cancers.”

The 14th Asian Symposium on Hepatology and Laboratory Medicine (ASCPaLM 2016) was held in March 2016. A large number of domestic and foreign physicians and experts and scholars were present at the conference.

  • Invited speaker from United States:  Afsaneh (Eva) Motamed Khorasani, PhD                                                                                                  “The Utility of DR-70, a Novel Blood Biomarker, in the Early Detection of Many Types of Cancers”
  • Invited speaker from Turkey:              Bedri Toker, MD,                                                                                                                                              “Onko-SureDR-70 in the clinical application of gastric cancer”
  • Invited speaker from China:                Wang Huiming, deputy director of China Medical University Hospital, Department of Surgery      “Onko-SureDR-70 in colorectal cancer, after tracking the clinical application”
  • Invited speaker from Taiwan:             Chenjun Jia, gastroenterology  physician in Taipei Veterans General Hospital                                  “Onko-SureDR-70 on track after clinical liver cancer application”

Dr. Afsaneh Motamed Khorasani is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedical science and clinical trial/research. She has a tenured and diverse range of experience in medical affairs, basic and industrial clinical research and development, clinical trials, Medical and regulatory writing and intellectual property. She is currently the Vice President of Medical Affairs at Easy Global Training, which is a US-based firm providing global regulatory, quality and medical affairs training backed by consulting. Before joining this company, Dr. Motamed Khorasani has served as an independent consultant, director of medical affairs, senior medical sciences liaison, senior scientist and senior medical analyst at Merck (MDS), Johnson & Johnson, United States Pharmacopoeia Convention (USP), Amgen, Baxter International, Covidien (eV3), Radient Pharmaceuticals, AMDL Diagnostics, Microbix Biosystems, Neometrix Consulting, Mount Sinai Hospital, Princess Margaret Hospital, and Vancouver General Hospital. She has more than 20 years of experience and many National and international certificates in GLP, GMP, ICH-GCP and global regulatory compliance for clinical trials and is a member in a number of professional associations, including: American Association of Cancer Research (AACR), American Medical Writers Association (AMWA), Regulatory Affairs Professional Society (RAPS), American Society of Quality (ASQ), Project Management Institute (PMI), and Intellectual Property Institute of Canada (IPIC). Dr. Motamed Khorasani’s research has focused on high throughput approaches in the context of cancer informatics with a particular interest in the use of comparative analysis for the mining of integrated oncology data sets that include protein-protein interaction and gene expression profiling. She has published and presented more than 50 papers, abstracts and articles in highly regarded scientific journals and high profile conferences and scientific meetings.

Feb 17, 2016
EASY GLOBAL TRAINING Entered a Joint Consulting Alliance Agreement with RJR Consulting Inc.

With the growing trends of competitiveness, one of the goals of us at EASY GLOBAL TRAINING is to collaborate with entities that strengthen our presence and branding in the industry. We are looking for consultancy firms in the areas of regulatory affairs, quality compliance, and medical affairs at the global level to increase our presence to be able to better serve our customers around the globe. For the extended list of our services in each of these three consulting areas, please visit “About Us” page on our website. Following this strategy, we just entered a joint consulting alliance agreement with RJR Consulting Inc. Based in Ohio, USA to further strengthen our regulatory service coverage around the globe. We are continually looking for well known companies in the area of regulatory affairs, quality compliance, and medical affairs with global coverage to form strategic collaborations in order to expand on the outreach and quality of the services we can provide to our customers at the global level.

Jan 08, 2016
EASY GLOBAL TRAINING Entered an Agreement to Provide Medical Affairs Consulting Services for SBLA Filing of KEYTRUDA® (PEMBROLIZUMAB) with FDA.

KEYTRUDA® (pembrolizumab) is a prescription medication that is used to treat Advanced Melanoma, Non-Small Cell Lung Cancer (NSCLC), and Head & Neck Squamous Cell Cancer (HNSCC) through activating body’s immune system. However, this drug can potentially cause your immune system to attack normal body tissue and organs, which can at times become serious or even life-threatening. If this self-attack happens, certain symptoms may appear, including:

  • Lung problems specifically pneumonia;intestinal problems specifically colitis;
  • Liver problems specifically hepatitis;
  • Hormone gland issues specifically in the thyroid, pituitary, adrenal glands, and pancreas;
  • Kidney problems specifically nephritis or kidney failure; or
  • Problems in other organs (eyesight changes, severe muscle or joint pains, severe muscle weakness, anemia, and rash)

You need to immediately call your doctor in case of any of these symptoms. The clinical trials are still ongoing. For more information and to get updates about this drug, please follow the manufacturer’e news at https://www.keytruda.com/information-about-keytruda/https://www.keytruda.com/information-about-keytruda/

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