The Risk Management Plan - an evolving document

In May this year I was fortunate to attend the European Medical Writers Association (EMWA) Spring Conference Symposium on risk management. Representatives from pharma, medical writing, the European Medicines Agency (EMA), as well as patient experts gave their perspectives on the risk management process currently in place. In Europe, a risk management plan (RMP) is required by the EMA as part of the approval process. As a medical writer, I've found the writing of these document to be a little challenging, particularly as the process and format is still evolving.
Here are some thoughts based on my experience of writing RMPs and from what I picked up from the Symposium:

• The process is still evolving, and therefore, the feedback received from the regulatory authorities on each RMP may vary depending on who reviews the RMP. So, content that was acceptable in one RMP, may be queried in another.
• The RMP template is under review and needs to be simplified.
• Part VI, the public summary, is also under review and may be updated to appeal more to a professional audience since patients are more likely to access relevant information about a medicine from European Public Assessment Reports (EPARs) and package leaflets. As a writer, this is good news since there are some inconsistencies in this section, notably the requirement for lay language yet the titles include one about 'epidemiology' which is not a widely used word in everyday speaking.
• Local RMPs may be required for a particular product if there are country variations in the information required to be included. This makes version tracking, especially when updating the information, particularly challenging.
• As writers, all we can do is ensure we follow the template and guidance, present the information clearly and succinctly, use correct and consistent grammar, spelling and formats and check the quality before submitting.

 

Kathryn White is owner and director of Cathean Ltd Medical and Copy Writing Services. She is a published medical, copy and equestrian writer with a passion for creating compelling text in collaboration with her clients. Her customers include pharmaceutical, healthcare and equestrian businesses across the world. 

Spring Medical Writing Freelance Retreat 2015

Group discussion

This month our band of merry freelancers got together to discuss challenges we face as solo business owners in Cathean's annual freelancer retreat. The energy in the room was incredible!

Who's got your monkey?

Our experienced freelancing colleague, Debbie Jordan, gave an insightful talk containing lots of useful tips for managing our time more effectively, including the brilliant game of 'who's got your monkey'!. This generated lots of discussion and gave plenty of food for thought.

Somatics can help you manage your stress response

We were then treated to an interactive coaching session on somatics by Dawn Bentley of Aurora Business Coaching. Somatics involves looking at how our physiology and body language impacts the way we deal with stressful situations and gives us ways in which we can modify our responses to promote calm and productive interactions. I have had the privilege of coaching with Dawn on a 1:1 level in this area and was keen to share some of the key points with our group as I has really revolutionised the way I enter potentially challenging situations. We practised a grounding technique which is an excellent way to help us manage our embodied stress responses which are learned and developed through our past experiences. This is a particularly useful technique for dealing with challenging situations both at home and in business.

Leading and following exercise

This was followed by an interactive exercise looking at leadership. As business owners it is important we learn the art of self-leadership first and foremost as we change our mindset from that of employee to employer. However, it is also important for us to be mindful of how we are led, given our interactions with clients. The exercise that Dawn gave us to demonstrate our leadership and following styles was fun as well as informative.

I shared my experiences of the Uplevel Your Business Live event I attended last year in Atlanta, with a particular emphasis on the different income streams available to us as freelancers. Finally, we had a lively discussion on the current challenges we face as a group when negotiating rates and project scope with clients. As feedback from the group suggests, the Retreat offers a great opportunity to share our experiences with like-minded people. As a freelancer you can feel quite isolated, with many of us working alone from home. So, getting together with our colleagues in an informal setting makes us feel like we are not alone in the challenges we face. And as they say, a problem shared is a problem halved!

Fabulous freelance friends

Kathryn White is owner and director of Cathean Ltd Writing Services. She is a published medical and equestrian writer with a passion for creating compelling text in collaboration with her clients from pharmaceutical, healthcare and equestrian businesses across the world.

IWMT 2015: Meet event organiser, Tissie Reason

Tissie  Reason is a long-standing member of the eventing community and has supported the Ian White Memorial  Trophy since its inception. Here, Tissie tells us how she became involved in the sport, and gives us an insight into the life of an organiser.

How did you become involved in eventing?

Tissie and Tarquin in action, Stokenchurch Horse Trials

I competed, mainly on a super grey called Tarquin with whom I did Pony Club and then British Eventing competitions. The legendary Dick Stillwell was my mentor. Our jumping was great but dressage was always a challenge, so Dick sent me to Alison Oliver [former trainer of Princess Anne] to sort this out!

How long have you been organising horse trials, and in particular, Smiths Lawn?

My first involvement in organising was at my family's farm in Bucklebury - the Bucklebury Horse Trials ran in the late 1960's until the mid 1980's - which my brother organised and I did the secretarial work. In the late 1960's I organised the Crookham Horse Trials at Tweseldown. I started Smiths Lawn Horse Trials in 1981 on the site of the former Windsor Horse Trials after they moved into the Deer Park to become a three-day event. The cross country track was not being used and the then deputy ranger of Windsor Great Park, Roland Wiseman, was keen to see the event continue at the lower levels.

What other events are you involved with?

I am entries secretary for Aston-le-Walls Horse Trials plus their dresssage, combined training and arena eventing competitions, Rockingham Horse Trials and Catton Park Horse Trials. I also enjoy helping at other events, particularly Blenheim and at the Horse of the Year Show where I am chief rosette steward.

HOYS 2014

Why did you become an event organiser and what has been your highlight so far?

I wanted to put something back into the sport which had given me such fun. Rather cliche, I know, but true. The highlight was joining the organising committee of Chatsworth Horse Trials in 1998 and then becoming Director in 2009.

Tell us more about Smiths Lawn Horse Trials

The beautiful Royal Park provides a unique venue. We are privileged to run an event here. The polo games held at the neighbouring Guards Polo Club present their own challenges as we do our best to ensure neither discipline adversely affects the other. I remember Claire Balding's mother saying how nice it was when her daughter was eventing here and her son was playing polo because they could see both at the same venue on the same day!
The most recent challenge was moving the cross country course from around the lake near the Savill Gardens to the private area where it is now, behind Cumberland Lodge. This has better going and have given us more space while avoiding the public area by the children's playground. This year I look forward to even more improvements to the course by Andrew Hunter and his team.

Why did you become involved in the Trophy?

I knew Ian when he was competing. He epitomised the continued appeal of eventing to owner-riders. I wanted to support Kathryn in her mission to raise funds for and awareness of brain tumour research.

How do you relax 'out of season'?

Tissie out cubbing with Mosquij

I enjoy hacking with Mosquij, now 21 years old, who my brother bred and my daughter events, and walking my two Jack Russells. I also enjoy amateur dramatics, reading, swimming, going to the theatre and nice restaurants.
You can catch up on the latest news from Tissie and her team at Smiths Lawn on Twitter: @SmithsLawnHT and on Facebook  

Kathryn is owner and director of Cathean Ltd Writing Services. She is a published medical and equestrian writer with a passion for creating compelling text in collaboration with her clients from pharmaceutical, healthcare and equestrian businesses across the world.

IWMT 2015 sponsor: meet Gill Watson

Despite stepping down from her role as trainer to the British junior and young rider event teams in 2011, Gill Watson is still playing a key role in British eventing.  She now coaches elite riders in the World Class Development squad and helps riders from all levels of the sport. So, where did it all start and what drives her undying enthusiasm for the sport? 

Gill started eventing at an early age as a Pony Club member and went on to establish herself as a successful event rider in her own right. In 1968, she was first reserve on her own horse, Shaitan, for the British squad at the Mexico Olympics, which won the first Olympic Team Gold for Great Britain since 1956. However, the highlight of Gill’s riding career was winning Burghley the following year, again riding Shaitan. It is this win which she believes opened many channels for her both as a rider and a coach. 

Her inspiration to teach is attributed to Pat Smallwood with whom Gill trained to attain her BHS qualifications. Not only is Gill a Fellow of the BHS and a FEI listed dressage judge, she gained teaching qualifications at degree level in Physical Education. During this time, riding and competing were still her preference, but as Gill explains, “The teaching helped me to earn a living.” In 1980, Gill was asked to coach the British Junior team. Then, just a year later, her remit as coach expanded to include the newly formed Young Rider team, accommodating riders from 18 to 21 years old. Gill continued to compete herself but quickly realised that her riding and coaching were in conflict with each other. Without the horsepower available to succeed as a competitor, Gill decided to pursue her career as a coach - and what a success story this has been.

Lilly Watson - Gill's co-trainer!

Under her leadership, the British Junior and Young Riders won over 100 European medals (individual and team), of which 46 were gold. Many well-known riders on today’s eventing circuit began their careers in the Junior and Young Rider schemes, such as Pippa Funnell and Zara Phillips. However, coaching is not without its challenges. As a trainer in any equestrian discipline, you have to be adept at dealing with two personalities: the horse and rider. In eventing, Gill has the added dimension of teaching skills in three different disciplines (dressage, showjumping and eventing) and combining them to achieve great results. Gill explains, “You can never stand still as a coach. You have to keep up with changes and the increasing competition from abroad.”

With this amount of success already under her belt, one wonders what ambitions might still remain unfulfilled. Without hesitation, Gill responds, “To keep producing good young people to go on. I still get very excited when I see talented people.” Gill is highly motivated in her role and gains inspiration from speaking to coaches across sporting disciplines. She enjoys listening to other successful trainers to explore different training methods and understand the psychology of coaching. Her skills as a teacher and mentor to riders of all ages and abilities are without doubt. It doesn’t matter what level her pupils are competing at, amateur or professional, her goal remains the same: to ensure they enjoy what they are doing and help them to achieve their aims - whether it be to compete at pre‑novice level or at Badminton. 

With such a highly personable yet talented and committed coach to support our World Class Development riders, I can’t help but believe that Team GB’s long-term success is assured.

Kathryn is owner and director of Cathean Ltd Writing Services. She is a published medical and equestrian writer with a passion for creating compelling text in collaboration with her clients from pharmaceutical, healthcare and equestrian businesses across the world.

Prize winning corner: IWMT 2014 runner-up receives NLP coaching

Michele Kevill and her horse, Diamond Marley, won the runner up prize in the Cathean Limited Ian White Memorial BE100 Class at Smith's Lawn Horse Trials 2014. The pair finished on their impressive dressage score of 26.0. The prize was a coaching session with Elizabeth Hough from Your Great Mind Coaching. Here is Michele's account of her experiences at Smith's Lawn and working with Elizabeth.

On the day of Smith's Lawn Horse Trials I was more excited than usual as I was travelling down to the event with my great friend and her horse, as well as my mother and our trainer. We all talked and laughed so much on the way down so the journey seemed very quick.

On arrival, my mother went off to collect numbers and we prepared our horses for the dressage.

Michele and Mousse out hunting (photo courtesy of M Kevill)

Diamond Marley (or Mousse as he's known in the stable) behaved appallingly in the warm up and screamed for his travel mate to the point where someone asked if he was a stallion! However, this worked in my favour as usually he switches off in the dressage arena but that day he stormed down the centre line and really showed off and we received our best mark ever! I then walked the show jumping which was up to height, this pleased me as my horse is easier when the fences are bigger. Then we walked the crosscountry course which was lovely with really good going for the time of year. 

I returned to the lorry full of confidence. When it came to the show jumping my horse reverted to his earlier behaviour, adding a few whip rounds and bucks for good measure which very nearly put me on the floor. When it came to doing the business in the ring he completed with a lovely clear followed by a storming crosscountry round. Gosh! I was so pleased with my boy especially as he had been very ill the season before.

I could hardly believe it when I saw the score board, 2nd place was not what I was expecting and I felt really proud. The sponsors were extremely generous; I received so many wonderful useful things but best of all I received a voucher for a session with Elizabeth Hough. 

Photo courtesy of M Kevill

Initially I felt apprehensive as I didn't really know what to expect, but having spoken with Elizabeth on two occasions I was confident that my visit to her would be beneficial. I really enjoyed my session, it was a lot to take in in a very short space of time. As yet I have not been to any competitions to apply what I learnt but I have used it when just riding at home to great effect. I feel a lot more confident in myself and my riding since my session and can't wait for the season to start.

I shall hopefully be back to Smith's Lawn again this year as it is a favourite event, well run, good courses and amazing prizes!

Kathryn is owner and director of Cathean Ltd Writing Services. She is a published medical and equestrian writer with a passion for creating compelling text in collaboration with her clients from pharmaceutical, healthcare and equestrian businesses across the world.

Prize winning corner: IWMT 2013 winner visits Piggy French

Caroline receives her goodie bag 

of prizes from Kathryn White (Photo courtesy of Fiona Scott-Maxwell)

Caroline Underhill and her horse Copper Clover (aka Chester to his friends) were the lucky winners of the Cathean Ltd Ian White Memorial Trophy BE100 class at Smith's Lawn Horse Trials 2013. Not only that, but they won the best turned out prize, the Willow Trophy, too! Successful international event rider, Piggy French, generously donated a training session to the trophy winner at her yard in Northamptonshire. Given Piggy's hectic schedule plus Caroline's busy life trying to juggle her eventing around her day job of accountancy, it was a minor miracle that they got a date in the diary, but they did! "I had a lovely time at Piggy's, thank you. It was a freezing cold foggy day but I had a really good jump lesson and Chester behaved himself and didn't embarrass me. Piggy was very welcoming and friendly and made me feel very relaxed." Good luck to Caroline and Chester for the forthcoming season, and we hope to see you at Smith's Lawn again this year. A big thank you to Piggy French for her generosity and to her team for being so helpful in organising a date.