All posts by Business Review Webinars

Spotlight Interview – Pavel Marek CEO NEOX

February 27, 2014 Business Review Webinars Leave a comment

Pavel Marek, MD, Founder and CEO of NEOX.

I am glad that through this webinar we have the opportunity to address not only our present and future partners & clients, but also the clinical research community as a whole. During our more than 10 year history we have accumulated a vast amount of experience which we want to share. Our motivation behind this is not strictly related to business. We are strongly focused on quality, and I have personally observed that the best way to push one´s limits is to expose oneself to the vast ocean of external opinions, views and ideas. I am sure that we have a lot to say, but at the same time we always want to learn more; however, this is impossible without the free exchange of experience. This webinar can be an ideal tool for such an interchange. I hope that you will enjoy its content, and I look forward to hearing your ideas and opinions.

1. What should participants expect to learn from the webinar?

There are three main topics we would like to address:

First, we are aware that clinical trials are becoming more and more global. That is why we would like to address the question whether there is still something which makes the region of CEE attractive compared to other emerging regions, such as East Asia or South America. Obviously, our answer is yes, and we would like to give you a few facts to prove it. Second, we are aware of how regulatory hurdles can influence time limits of the study. Our regulatory affairs director will tell you more about overcoming these hurdles. And third, we know that it is sometimes difficult to find common ground between US-style contracts required by sponsors and continental contractual approaches acceptable to the sites. We would like to hear your feedback and will be happy to share our ideas about it as well.

2. Can you describe your company ’Neox’?

My brother and I started the company together back in 2004 with only three people. We were a classic small CRO offering mainly monitoring services at Czech sites. Now, we have grown to around 200 employees, and we are active in the Czech Republic, Slovak Republic, Poland, Hungary, Germany and also in the Nordic countries. I am proud that we still stick to the original tenets that were present when we founded the company. We are dedicated to maintaining our local expertise and focus on quality.

3. What do you most enjoy about your role?

My greatest pleasure is being involved in an ever-evolving landscape of medical research leading to new clinical trials. I feel proud when I see that our clients appreciate our services and want to stay with us. It is refreshing for me to be in the center of our relatively young team of likeminded people. All these factors are important drivers of my enthusiasm.

4. What movie would you recommend to watch and why?

For relaxation, I certainly recommend anything directed by Quentin Tarantino. On the other hand, why not to switch off the TV and relax with a good book instead?

5. What is your favorite place in the world and why?

Prague, unsurprisingly. It is a magical city, and anyone who has ever seen the silhouette of Prague castle at dawn or dusk knows why.

To view the live webinar sponsored by NEOX Clinical Research register today here

Spotlight Interview – Paul Otway, JEE

February 27, 2014 Business Review Webinars Leave a comment

Paul Otway, Senior Subsea Engineer

Paul has extensive experience in subsea pipeline design and integrity projects for global operators. His particular focus is the management of pipeline ILI campaigns including technical definition of pigging campaigns, pig selection/design, review and HAZOP of procedures and offshore management of pigging operations. Paul won the Subsea UK Young Emerging Talent award in 2013 for his ILI work.

1. Why did you decide to do a webinar with Business Review Webinars?

At Jee we are not just an engineering consultancy, we are also a training company. We are passionate about sharing lessons learned and using our 25 years of engineering experience to train the industry. It’s a privilege to be able to pass on some of our knowledge to our loyal customer base as well as those less familiar with Jee.

2. What is your favourite thing about presenting and why?

My favourite thing about presenting is the opportunity to share knowledge and opinions on subjects that interest me and gaining feedback from those present. In my day-to-day working life, presentations are usually an opportunity to share project plans or technical ideas with other interested parties. I prefer to use presenting as the basis for enabling a thoughtful and productive discussion rather than simply a lecture by me to others. PowerPoint and other presentation software are powerful tools and very useful for providing structure to a presentation, but all too often they are relied upon to include all the detail as well. The visual presentation should not be a distraction to the audience, and the focus should always be on what is being said rather than what is on the screen. I find this allows a more open environment and others feel more comfortable to interrupt and ask questions. Presenting online will be a new experience for me with new challenges as it does not facilitate that multi-way discussion throughout the presentation.

3. What do you wish other people knew about Jee?

That we have engineering capabilities spanning the whole life-of-field! All too often our clients use us for a particular service or discipline, and because of the high standard of technical service they receive, they presume this is our specialist field. In reality our capabilities and dedicated discipline divisions could give them the confidence they have with Jee on all their projects.

4. What do you most enjoy about your role?

One aspect I really relish about my role is that it allows me to get very actively involved and invested in long-term projects, building relationships over time with those I work with, including clients, colleagues and 3^rd parties. Some of the projects I have undertaken have been very high-profile within the client company, and have included significant technical challenges. I feel fortunate to have had these opportunities and been entrusted with such responsibilities so early in my career as it has allowed (and forced) me to develop and learn rapidly as well as being able to specialise early in an area and technology that is evolving and developing all the time.

5. Where would you recommend visiting in the world and why?

Based on places I have been (rather than places I want to go) I would highly recommend Rio de Janeiro. I visited Rio for two weeks in 2007 as a student and had an amazing stay. The city and the landscape around are absolutely stunning and it is an incredibly vibrant city which I found to be very welcoming to tourists. There are so many things to do and see in Rio (Cristo Redentor statue, Sugar Loaf mountain, Ipanema and Copacabana beaches). I even managed to get to a Rio football derby between Botofogo and Fluminense at the Maracana, and that is where you see the real Brazilian passions come out. While there is an undeniable edginess about the city with such wealth and poverty situated literally side by side on many streets, at no point did I feel unsafe or vulnerable. So long as you have a little common sense there is little to worry about and the people are generally incredibly friendly – however if you do insist on wearing a Rolex and having a £2000 camera on show you may well make yourself a target. With the World Cup in Brazil this year and the Olympics in Rio in 2016, I can think of at least two great excuses to visit Rio!

To listen to Paul Otway discuss the topic ‘In-Line Inspection: Ensuring Fitness for Purpose of Subsea Pipelines’ register for the webinar here

Spotlight Interview – Michael Hodgson TEKLA

February 27, 2014 Business Review Webinars Leave a comment

M. Hodgson has worked in the construction industry for over 25 years in various roles, from Fabricator to Draftsman to 3D CAD CAM software solutions supplier. As Technical Manager in Tekla Corporation, he facilitates numerous projects such as the Rayong Oil Refinery in Thailand, and London Heathrow Terminal 5, and is actively involved in the implementation of BIM technology in projects worldwide.

1. What is the most informative fact of the webinar?

To educate how Tekla Structures can be used for the detailing, engineering and construction all variations of offshore projects

2. Who or what was your inspiration for getting you into this industry?

My Brother who is a ASME coded welder and who is passionate about his work

3. What gets you up in the morning to come to work?

I enjoy my role as Technical Manager very much, working for a company like Tekla is a pleasure and give me the opportunity to be involved in fantastic projects from the inside

4. What’s the most interesting thing you’ve done within your current role

Back in the 90’s being one of the first to implement 3D software into a company and then linking that software to CNC machines, it had never been done before and set the standard for the industry.

And finally …
Porsche or BMW? Neither Ducati

Laptop or Tablet? If I had to choose it would be difficult but Laptop
Red or white wine? White all the way
Soccer or tennis? Hate both

To view Michaels Upcoming webinar sponsored by TEKLA discussing Impacts of 3D Modelling on Offshore/EPC Structural Engineering Projects register here

Vaisala: Sensor Placement in Validation/Mapping

February 20, 2014 Business Review Webinars Leave a comment

Sensor Placement in Validation/Mapping: Where & How Many?

Hi, my name is Paul Daniel, I am the Senior Regulatory Compliance Expert at Vaisala with 16 years of validation experience in the pharmaceutical and medical device industries. Vaisala is a world leader in innovative solutions for measuring environmental parameters; we provide environmental monitoring, measurement and validation systems designed for life science applications.

In today’s global economy, drugs, biotechnology and medical devices are shipped all over the world. To ensure these temperature-sensitive products are stored correctly, new and revised regulations have been developed in many areas, including China, Europe, and the U.S. Universally, these new Good Distribution Practice (GDP) regulations recommend performing mapping studies to qualify storage areas. The two most common questions I hear regarding mapping studies are: 1) where to place sensors, and 2), how many sensors to use. My webinar will directly address these questions, discussing five rules to apply when creating a rationale for sensor placement in mapping studies.

Global regulators, including the Food and Drug Administration (FDA), the European Medicines Agency (EMA), China’s SFDA, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) require manufacturers to determine if environmental parameters affect product quality and perform stability testing to determine appropriate product storage specifications. It is the job of those in the “cool chain” to help ensure that those storage specifications are met. Unfortunately, most regulations offer little guidance on how to perform a mapping study. For example, the location and number of sensors that are needed to qualify a given space are not dictated by the regulations; it is left to manufacturers and distributors to determine adequate sensor placement as part of their quality processes.

In addition to recommending mapping studies, the new GDP regulations explicitly assign responsibility for following the GDP regulations to the entire distribution network. Practically, this means that a large number of previously unregulated entities must now secure their portion of the cool chain, and that will include performing mapping studies. This has created a demand for clear and concise guidance to support mapping studies, and at the forefront of this demand are the two questions raised previously: 1) where to place sensors, and 2), how many sensors to use. To meet this demand I developed the “5 Rules of Sensor Placement”. These rules are based on my years of practical experience, and I have verified them against recent guidance from the USP, PDA, and ISPE. It is my hope that these clear and concise rules can guide a new mapping practitioner to a reasoned rationale for sensor placement in mapping studies, and supply much needed guidance in this critical activity. Here they are:

Rule 1: Map the extremes.

Rule 2: Map in 3 dimensions.

Rule 3: For large spaces, map storage only.

Rule 4: Identify and address variables.

Rule 5: If it’s worth mapping, it’s worth monitoring.

You can use these rules as part of a plan to create an accurate profile of storage conditions through a consistent validation program. This will establish that the environment is adequately understood, documented and controlled; and it will also it demonstrate that it is safe for sensitive products and compliant with GDP. Moreover, the information obtained from reasoned, well-executed mapping studies will inform decisions on how controlled areas are monitored continuously, making monitoring choices evidence-based. Such an approach to monitoring temperature, humidity and other critical parameters ensures that any auditor or inspector will find a shining example of environmental control when they visit your facility.

I hope you will join me for this presentation that is designed to give those new to validation the fundamental methods of determining sensor placement in mapping studies. We at Vaisala are experienced in delivering webinars and love to hear feedback, here is an example from a previous webinar:

“Vaisala’s webinars are wonderful — especially for someone who is trying to learn as much as possible about this field, but comes from a very different background and is on a limited budget.” Danielle, Validation Technician

To view the Vaisala webinar live on April 8 2014, click here

I have attached a link to view some webinar highlights for ‘Video Validation for GxP Environments’: http://www.youtube.com/watch?v=ygCu3cA9BMk

An example of a relevant Case Study

McKesson Delivers Pharmaceuticals Safely & Reliably with Standardized Environmental Monitoring in 60 Distribution Centers http://www.vaisala.com/Vaisala%20Documents/Success%20Stories/CEN-LSC-AMER_McKesson_Success%20Story%20LOW.pdf

Exemplified below is a relevant whitepaper

How the Vaisala Continuous Monitoring System Aids Compliance with Title 21 CFR Part 11 and EU GMP Annex 11 http://www.vaisala.com/Vaisala%20Documents/White%20Papers/CEN-LSC-G-Vaisala-CMS-Part11-Annex11-WhitePaper-B211305EN-A.pdf

Share your opinions and experiences

See the Vaisala Life Science Blog where our Subject Matter Experts and industry contacts share their expertise and experience. New blogs every week! Check http://www.vaisala.com/en/lifescience/blog/default.aspx

Collaboration between Covance and Business Review Webinars on upcoming webinars in 2014

February 17, 2014 Business Review Webinars Leave a comment

Business Review Webinars, a thought portal leader for business professionals in the pharmaceutical, healthcare, energy, supply chain, packaging and food & beverage, today announced their collaboration with Covance to promote a series of webinars in 2014.

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 12,000 employees in 60 countries and has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today. The first of Covance’s webinars will discuss how the biopharmaceutical industry must address Regulatory, Scientific, Reimbursement and Commercial audiences, each of which requires a different type of writing. This can lead to extended development and release time lines and create cost ineffiencies within the organisation. This webinar will take place on the 1^st April 2014 at 5pm UK time and 12pm New York time.

Key learning objectives:

Understand the different types of writing and their integration to support product commercialization.
Understand the how to write for the different audiences.
Understand the different skills required with each type of writing.
Learn why an integrated approach can provide more impact and also be more efficient.

To sign up for this webinar, please visit

http://www.business-review-webinars.com/webinars?chan=pharma

Business Review Webinars allows individuals throughout the world to learn and to communicate. Particularly in the past two years, webinars have rapidly gained prominence as an important component of many marketing strategies. No longer considered an afterthought, a well-crafted and successful webinar can greatly enhance a company’s reputation, sales and benefit the audience as a progressive learning tool. Business Review Webinars deliver high level thought leadership presentations on intriguing and current topics, which appeal to a live audience. Ultimately, the key to designing a good, relevant webinar is in understanding what an audience is looking for.

“We’re looking forward to working with Covance on this new webinar series and are pleased that we have been chosen to leverage promotional aspects of their webinars”- Jake Sharp, Head of Business Review, Progressive Digital Media PLC

For more information on our upcoming webinars, please visit the following link:

http://www.business-review-webinars.com/webinars?chan=pharma

__________________

About Covance

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 12,000 employees in 60 countries. Through its lead optimization, nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

______________________

About Business Review Webinars

Business Review Webinars (BRW) was established in March 2010 as part of Progressive Digital Media Group Plc. BRW is a thought leadership portal for business professionals in the pharmaceutical, healthcare, food & beverage, energy, packaging, supply chain and defence industries. BRWs’ goal is to create high level discussion between industry thought leaders and business professionals who are actively facing the day-to-day challenges of their respective industries. Webinars are free to register with and attend, and topics are based around an editorial plan established by our leading editors and analysts.

A journey from a welder to developing model-based software

February 11, 2014 Business Review Webinars Leave a comment

Michael Hodgson

It’s a Sunday morning in early February and it’s finally looking quite nice outside after a month of consistent rain and storms which has given me quite a while to reflect on this Offshore Webinar and the Offshore construction / fabrication industry in general.

I missed the golden years of Offshore Platform Fabrication in the UK which mainly occurred during the 1970’s an old boss of mine however was involved in RIG design in those days and I always remember him telling me nobody had any idea what they were doing and you could pretty much charge what you wanted to for any offshore rig design / detailing work. As we all know those days are long gone and anyone involved in offshore construction finds themselves in a very highly competitive and in many ways ruthless market.

My career started when I left school at 16 being and from an industrial northern UK city almost everyone went into heavy industry, for myself it was to work at a local structural steel fabricators, it was your typical company started just after war with very little investment and no modernisation / investment for decades and a scant regard for health and safety, I started as a welder / fabricator which meant we did everything from running machines to loading trucks for delivery, the company was eventually bought out by a big mining consortium who put the investment that was so desperately needed for its survival .

During this time I obtained my welding qualifications and had an opportunity to move into the drawing office just as computerisation and automation in the workshop was being introduced , I want back to university in the evening to study diplomas in CAD/CAM while at work, the first 3 dimensional structural steelwork system was implemented (the first in the UK).

Along with a colleague Inevitably we started working for the software company and I was immediately assigned to an EPC / Offshore Platform project in South East Asia where I had to demonstrate the capabilities of the software then implement train, integrate to analysis and design software’s and finally link to workshop floor CNC machinery, most of this had never been done before and there was no one to ask for assistance we had to figure most things out by ourselves, I don’t know how many people reading this found themselves in the same situation ?.

From this point I then further qualified on as a C++ certified programmer, MCP, MSCE, MCT and certified professional presenter always in the structural industry.

As we look at today’s offshore industry it’s amazing how far things have moved on even from those pioneering days, with 3 dimensional pipe cutting machines, plate plasma cutting, workshop simulations and true integrations of software platforms make these fantastic times to be in our industry.

I’m very pleased to be asked to present our webinar.

We will cover an the construction life of an offshore platform all the way from conception to detailing, fabrication and yard assembly, utilising the latest and best tools for the project with all of this is based around our central software offering Tekla Structures where we will show you how Tekla Structures is the main focal point of the whole project.

I hope you enjoy what we have to show and look forward to hearing your feedback register here to secure a place.