All posts by Business Review Webinars

Are you prepared? The transition to Identification of Medicinal Products (IDMP)





The submission of data regarding human medicinal products in the European Union has been a requirement since July 2012 when it became mandatory to supply information to the Extended Eudravigilance Medicinal Product Dictionary (XEVMPD) of the European Medicines Agency (EMA).

Was it a challenge for you to collect, store, check quality, process and submit the required data within the defined timelines?

This led to many technical and process issues, which, in turn, have led to significant issues with the quality of the data held by the EMA.  Overall, the quality is considered to be less than adequate to use for the intended purposes of support for pharmacovigilance activities.  In addition, there are many issues with the Controlled Vocabularies utilised and further expanded during data collection, particularly for Substances and Organisations (MAHs).  These are in the process of being addressed but it will mean significant rework will be required.

Lessons need to be learned from the issues of XEVMPD.  Racing against deadlines with ill-defined guidance and poorly defined and controlled vocabularies has to be avoided and so to avoid a similar painful experience when IDMP is implemented, early assessment and planning is recommended.

What steps have you taken so far?

MAHs have an opportunity to prepare and consider a better way to manage medicinal product information within their organisation. IDMP will require data from a much wider set of functions with a pharmaceutical company and so Regulatory Information Management systems will needs to have a wider reach and/or sourcing of data.

Getting to grips with IDMP will be a significant challenge and there will be many ways to address the needs of IDMP.  The assessment of the impact of IDMP within a company and the challenges and opportunities that it will bring should be initiated as soon as possible.  To delay will compress the timelines to prepare for the July 2016 implementation date and offer less opportunity to implement solutions and processes that will be efficient.

Join Andrew Marr, an active member of the ISO Committee and Sinisa Belina from INFOTEHNA on 4th December where they will be addressing the challenges and opportunities in transition from XEVMPD to ISO IDMP. Register here.

What level can YOU get to?

DSM pic






I’ve made it to level 3 so far! And a few others who I’ve sent the game to have had fun getting lost around the maze on Level 1. Have a go and see what you think of the new DSM Biologics game. They’ve developed it to celebrate the opening of their new cGMP facility in Brisbane, Australia. Let us know what level you get to.

Their new facility provides cGMP mammalian cell-culture contract manufacturing services from process development through to commercial manufacturing. Read the full report here.

Back in April DSM and DecImmune Therapeutics announced that they had signed an agreement to develop N2 Pathway Blocking Antibodies. Also, in October, DSM Biologics signed a new agreement with Opthea to manufacture their lead product for eye disease. This project represents an agreement for process development at DSM Biologics’ Groningen, the Netherlands, facility and manufacture at the newly established cGMP facility in Brisbane, Australia. You can read the full press release here.

Join DSM’s webinar ‘Going beyond flexible single use facility for achieving efficient commercial manufacturing’ on 19th November at 3pm London/10am New York. Register here.


Spotlight Interview: Steve Thomas

Steve ThomasSteve Thomas is a Scientific Investigator in the DMPK department at GSK Ware. Steve is responsible for structural identification of in-vivo and in-vitro metabolites. It is essential that GSK scientists have access to one another’s findings in order to prevent error, repetition or inefficiency. He has implemented a Spectrus database of metabolic knowledge that helps GSK store, share and search data from around the globe.


1. What message are you most looking forward to getting across to your webinar audience?

The efficiency of re-using data in a corporate environment. We are generating knowledge too fast to stay in one person’s head. I hope to show the audience one way to create a repository of knowledge that doesn’t forget, doesn’t go senile, doesn’t retire and doesn’t leave the company for a competitor.

2. Where is your favourite place in the world and why?

Any shallow tropical sea bed. As an avid scuba diver I love investigating the undersea world and its fantastic inhabitants.

3. How did you become a Scientific Investigator?

I have always loved puzzles and science. Structural identification is a straight combination of the two. I was lucky enough to train in both NMR and Mass Spec, flatteringly described as analytically bilingual. Initially this was geared towards Medicinal Chemistry support, but eventually the lure of more challenging samples and close proximity to the development compounds that would change people’s quality of life proved too strong. I have been a Scientific Investigator, studying metabolic transformations in man for 7 years.

4. What has been the best moment in your career?

Curiously, site closure. I was at Merck when Terlings Park closed. The camaraderie and skill sharing that helped the scientists there branch out and move on was human nature close to its best.

5. What are you hoping to achieve from doing the webinar?

I hope to give participants an overview of what can be done with linked up data so colleagues within an organization don’t have to reinvent the wheel and can steer away from known problems

Spotlight Interview: Robert Burke

Robert BurkeRobert Burke is the Application Manager at Wood Group GTS and has been working in power generation for 22 years. Robert’s experience ranges from overseeing turbine manufacturing, installation quality and hands on gas turbine installation performance. He has spent 13 years working with General Electric and six years working with Gas Turbine Efficiency.

1. What do you most enjoy about presenting to a live audience and why?

I enjoy having the opportunity to share best practices or proven technologies that have benefited others globally and can provide value for all people in our industry from students to C-level management.

2. What is one of the most informative facts in your upcoming webinar?

One informative fact is the gas turbine benefits for end users. These benefits include a 1-4% performance recovery, 0.5 -1% heat rate and 2% availability improvements. The addition or combination of Power Augmentation technologies have also shown to provide power improvements up to 15% and heat rate improvements up to 2.5% when in use.

3. What is the ideal outcome you would like to see by doing this webinar?

I’d like for people to better understand that innovative gas turbine technologies are available to them that can increase the performance of their assets.

4. What has been your best holiday and where would you recommend visiting?

During the Holidays I prefer staying relatively close to home. I recently spent 12 days in Wyoming with my wife where we covered Yellowstone & Teton National Parks. Here you can be in touch with the outdoors, including horseback riding, nature watching and fishing. I would recommend this trip to anyone.

Also, being an avid scuba diver I highly recommend visiting Phuket, Thailand. It is exotic and beautiful, but it is quite a distance to get to, living in the US.

5. What do you most enjoy about your position and where do you see yourself in 5-10 years in your career/what would you like to achieve in your career?

I enjoy developing and deploying new product technologies whilst in parallel, supporting a sales function in presenting these technologies to customers and the industry. I am interested to see where the Power Generation industry is heading from a technology perspective and what will be the next big change and how that change will it transform the industry or product evolution.


Quiz Question: In food-package design, what is the most popular colour for manufacturers to use?

A) White
B) Blue
C) Red
D) Green

Submit your answer in the comments below for your chance to win a prize worth £25!

The entry period is 5th November to 5th December 2013.

All entries must be received by midnight on 5th December 2013.

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Spotlight Interview: Sami Liponkoski

Sami Liponkoski, M.Sc.Tech (Chemical Engineering) has over 10 years experience in RFID tagging solutions and antennas, with a broad experience in RFID business, field engineering, technical solutions and converting. He is a member of management boards in several RFID projects; Manos (TUT), Ideal Hospital (HUS), RFID Lab Finland, NICE Travel.

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

We understood that BRW has a good reputation in the webinar market space. We believe that BRW has strong marketing and sales team to support our webinar promotion and reach out to a truly global audience.

2. Tell us more about your webinar you hosted with BRW? What were you hoping to achieve from doing the webinar?

My main incentive of hosting this webinar was to continue our marketing campaigns that we started earlier this year. We wanted to continue promoting the same message we launched at RFID Journal Live in Orlando which took place from 30th April – 2nd May 2013 Additionally we wanted to reach out to audiences we have not been able to approach, primarily the end users. Our first webinar went well and we now understand the importance of utilising social media as Business Review do reach out to a wider audience.

3. What was the presentation about? What did you explain to the audience?

My main message was to approach people who are already using or considering using RFID technology and additionally to reach new audiences that I have not had the opportunity to meet. In the webinar, I presented our new 4E Technology solutions to reduce cost of tagging which is important in the current economic climate. We wanted to use a different angle to ensure the audience understood how our solutions could make the difference. Please request our on demand presentation here.

4. Where is your favourite place in the world and why?

One of the best places is my home Coastal Areas and Archipelago in Finland. It’s one of the country’s most beautiful and most unique tourist destinations. It lies off Finland’s west coast. Shaped by the Ice Age, the Turku archipelago consists of over 20,000 islands and islets. The area is naturally popular with sailors, but the numerous islands mean that the area can also be explored by road on the circular Turku Archipelago Trail. Sheltered waters mostly mean light winds and calms seas. Finland is the perfect sailing destination if battling the nature is not high on your list of sailing preferences.

5. What do you most enjoy about your role?

I absolutely love the RFID industry. I want to be part of developing the technology and changing the world one tag at a time. I am very passionate and believe in our products. I enjoy introducing our new solutions and in general making our world a better place one step at the time.


dcrykfgTotal Clinical Platform Suite of eClinical Solutions Among the Short List of Nominees for 2013 Awards

STAMFORD, CT— October 24, 2013—ArisGlobal, a leading provider of solutions to the life sciences industry, is recognized as a SCRIP Awards finalist in the “Best Technological Development in Clinical Trials” category for 2013 for Total Clinical™ a cloud based platform of eClinical solutions.

The SCRIP Awards are the only awards to recognize innovation and excellence across the international biopharmaceutical industry. In November, the 2013 winners will be announced at a gala dinner in London.

“We are honored to be among the short list of nominees for this award,” said Simon Sparkes, senior vice president of ArisGlobal clinical business unit. “Total Clinical™ truly deserves this recognition as it is the only eClinical platform that completely integrates clinical operations and data management functions.  There simply is no other platform available that can support clinical development so effectively”

The awards provide the industry with an opportunity to acknowledge and applaud its highest achievers across all parts of the value chain, and recognize both corporate and individual achievement.  SCRIP are now in their 9th year, and winning is recognized as a superior achievement within the global industry.

The SCRIP editorial team say, “Deciding on a shortlist from so many deserved entries was never going to be an easy process for our independent panel of judges, but they rose to the challenge and this list displays the wealth of innovation, dedication and hard work that the pharmaceutical and biotech industries have demonstrated over the past year.”

About ArisGlobal

ArisGlobal ( is a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and quality & compliance for medical inquiries.  Solutions are available on premise or on a regulated cloud platform.   Life science companies using ArisGlobal’s solutions can better build and maintain the trust they need with their customers, medical practitioners and regulatory bodies around the world.

Kathy Capper

+44 (0) 1908 506075

[email protected]