Yearly Archives: 2022

With less than 70 days to the 31st October Brexit deadline and the heightened risk of a ‘no deal’. Governments and companies are finalizing ‘no deal’ plans.

What will the impact be for the Biopharmaceutical Industries?
The UK will be treated as a 3rd Country.

What does this mean?
1. All products manufactured in the UK must be QP released in the EU for the EU.
2. All products manufactured in the UK must be tested in the EU for the EU.

3. There are also associated risks to RoW Markets.
4. There is a risk of delays at borders in and out of the UK. How long these delays will be is unknown.

Are products only manufactured in the UK impacted?
NO, any product that has a UK ‘touchpoint’ is impacted.

What are Biopharmaceutical companies doing?
1. Reviewing and updating supply chains
2. Transferring release and testing out of the UK to the EU
3. Transferring distribution centers out of the UK to the EU
4. Stockpiling medicines where feasible

Are you ready ?
If you need any guidance or support in your final stages of planning e.g
1. Supply Chain review
2. Due Diligence Assessments
3. Warehousing/Distribution
4. Contract Resources – Project Management, Supply Chain, Quality

Please reach out to us TODAY www.independentsolutions.ie / info@indepedentsolutions.ie

Relevant links

http://www.hpra.ie/homepage/about-us/stakeholders/brexit/brexit—latest-information

https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit

https://www.bbc.com/news/amp/uk-politics-46393399

Are you ready for the Unique Device Identification (UDI) System requirement under the EU Medical Device Regulations 2017/745 and 2017/746 regulation – Effective May 2020?

Are you ready for the Unique Device Identification (UDI) System requirement under the EU Medical Device Regulations 2017/745 and 2017/746 regulation – Effective May 2020?

The European Medical Device Regulations for Unique Device Identification (UDI) will be effective May 2020, this mandates that any company supplying Medical Devices in the European Union are legally obliged to comply. Are you compliant?

May 2020, a Unique Device Identification (UDI) must be assigned by the manufacturer to every medical device, and every time there is a change in the product the manufacturer must evaluate the UDI. Are you ready for May 2020?

In this time of uncertainty, where there is global panic around the Covid-19, we need all the help we can get, I hope some of these pointers, which we can adapt when working from home will resonate.

Anxiety upsets our immune system, when one is anxious one doesn’t want to exercise or eat well, our immune system loves calmness and positivity. One can’t fight fire with fire or fight panic with panic!

1. Keep anxiety down by keeping a routine, get out of out of your PJs and make your bed.
2. Open a window, let fresh air in and circulate.
3. Try dry brushing before showering, it is a natural energy boost.
4. Start the day with a stretch routine. The Yoga practice, ‘The Sun Salutation’ is great to mobilize your body, your muscles will retain more of their functionality.
5. Try to exercise for 30 mins every day, movement releases blockages & it massively boosts your immune system.
6. Rise from your chair at least once every hour.
7. Do your best to support your last line of defence – your immune system. Ensure you are well nourished; limit fine sugars, junk food, preservatives & additives, these are hard on your system.
8. Eat foods that that make your body feel good. Boost your immune system by eating vegetables, Vitamin C. Herbs and spices like oregano, sage, cilantro, parsley, rosemary, ginger and turmeric help fight viral infections. Alliums like garlic and onion also stimulate protective immune cells.
9. Limit caffeine as it triggers anxiety
10. Hydrate Hydrate Hydrate, our bodies are composed of ~ 60% water.
11. Get out in Nature. Get as much sunlight, Vitamin D as possible. Trees are known to balance the nervous system. Go barefoot!
12. Raise your awareness, take in your surroundings, live in the now.
13. Pay attention to your posture, ensure your head is directly over your shoulders and your back is straight. When your skeleton is aligned, it reduces the amount of strain on your bones. When you hunch up over a computer, you are physically reducing how much space all of your internal organs have. One of the benefits of good posture is that your digestion will improve.
14. Pet an animal, animals absorb negative energies.
15. Continue to connect with people by phone, zoom or skype or even write a letter. We need connections.
16. Respond to events rather than react to them, how we react to a situation is the situation.
17. Give & Support each other, giving has its own rewards.
18. Surround yourself with positive people.
19. Practise self-care e.g. salt baths (cleanses negative energy), reading, singing, playing or listening to music, do what you enjoyed as a kid, the more intense the day the more self-care needed.
20. Meditate regularly, as you meditate you are healing, simply be, watch a sunset, listen to the sound of the ocean or smell the scent of a flower
21. Make the best use of lifestyle strategies to optimize the well-being of your body so you’re not so susceptible to attack.
22. Practice deep breathing. Deep breathing reduces the release of the stress hormone, cortisol.
23. Try The 4-7-8 breathing technique, also known as “relaxing breath,” which involves breathing in for 4 seconds, holding the breath for 7 seconds, and exhaling for 8 seconds. This breathing pattern reduces anxiety and helps to get one to sleep.
24. Control your thoughts, your thoughts control your feelings, your feelings control your actions and your actions control your events, in this time of uncertainty the one thing you can always control are your thoughts.
25. Be proactive rather than inactive.
26. Take a break from the news and social media
27. Start daily Journaling, there is a therapeutic benefit to committing thoughts to paper.
28. Repeat Positive Affirmations, Louise Hays one for viruses is ‘I lovingly allow joy to flow freely in my life’.
29. Practice Gratitude, what’s great about your life? Each day is a chance to start all over again.
30. Connect to a higher power.

We are all facing this pandemic, it is time to reflect on our interdependence and our interconnectedness.
We all love the idea of some time for ourselves, we never have enough time. Now time is forced upon us, so use that time to sort out your house, start to learn something new, read those books, do an online course or activate your creative side.
The past is history, the future is a mystery or anxiety and this moment is a gift
This Too Will Pass!