❗️Amendments to EU MDR 2017/745 you say? ❗️

I am conducting research on:

'What amendments can be made to the EU MDR 2017/745 to address the concerns of Class III medical device manufacturers?'

Initially, I am collecting survey responses to identify the areas of concern to manufacturers to subsequently gather input for potential amendments.

The survey can be found here:

https://lnkd.in/dQA4Tgte

I am struggling to get responses, due to the specificity of the area in research. Therefore, any and all feedback will be greatly appreciated.

Research Question: What amendments can be made to the EU MDR 2017/745 to address the concerns of Class III medical device manufacturers?

I am currently completing a Master of Science degree in Quality at the Institute of Technology, Sligo (Atlantic Technical University).
 
As part of my thesis, I would like to request your participation in a short survey titled:
 
"What amendments can be made to the European Union Medical Device Regulation 2017/745 to address the concerns of Class III medical device manufacturers?"

This survey has 9 question topics and will take no more than 15 minutes to complete.
 
The purpose of this survey is to gather information regarding the concerns of manufacturers across Europe in relation to EU MDR 2017/745 and to subsequently obtain input on the amendments that could potentially be made to the regulation to address such concerns.
 
The analysis of this survey will form part of the results and discussion section of the dissertation.
 
The implication of this study will be to present a formal, extensive study to the European Commission services in charge of medical devices to facilitate discussions on possible amendments or corrigenda to EU regulation on medical devices.
 
Your participation in this survey is completely voluntary and your responses are anonymous and confidential. There are no means of linking your input, to you, as a participant of this survey.

You will not be asked for your email address or any contact details to participate in this survey. However, an option will be available to submit your email address should you wish to participate in a follow-up activity.

To read about the data protection and privacy of the survey software used to collect this data, please visit https://cloud.google.com/privacy/gdpr

You can withdraw or opt-out at any point in the process by pressing 'Clear form' on the bottom-right of the form. Your responses completed up to that point will be cleared. Participants should then close the window to terminate the process.
 
If you have any questions about this survey, difficulty accessing the site or completing the survey, wish to fill out a hardcopy of this survey, or wish to provide further feedback, please contact me at ‘shauna.coen@mail.itsligo.ie’.
 
Thank you in advance for taking the time to complete this survey, your feedback is greatly appreciated.

Hello everyone,
I’m looking for some help please. My free online learning with LinkedIn has now come to an end. Does anyone know of any free online courses I could do to do with the pharmaceutical industry please?

Any help or advice would be much appreciated please.

Hello,
I am currently a Regulatory Affairs student at Humber College Toronto, Canada. I would love an opportunity to intern at a pharmaceutical or medical device company for summer 2021 or on a long term basis.

Ever wonder what you should be focused on to transform regulatory science and clinical research? Read what the regulators say we need to get rid of (hint: small crappy trials, says Janet Woodcock, MD, FDA-CDER director) and prepare yourself to embrace (and lead) change. https://www.clinicalleader.com/doc/regulatory-science-clinical-research-where-do-we-stand-and-where-are-we-going-0001

Hi Laura, 

I'me eager to learn more information about this open role. Please advise how we may continue the conversation. Thank you! 

We have an extremely exciting permanent REGULATORY STRATEGY role available with a drug development company in Switzerland. We are speaking to people at Senior Manager and Associate Director level. Please get in touch for more info

I head Medical Writing recruitment out of the east coast for Real Life Sciences. We are a global and publicly traded recruitment firm that specializes in pharmaceuticals.

Ten of my top clients are in urgent need of regulatory writers. Individuals who have authored and led regulatory submissions (IND, NDA, BLA, MAA). If you have done and led global submissions that's even better. My best clients are the top five pharmaceuticals by market share and revenue. Financial package is extremely attractive.

If interested send CV's too:

Email: a.rahat@realstaffing.com

Phone: 917-349-0833

 International Pharma CompanyLocation: Andheri Mumbai 6 to 8 Years with TGA and Medsafe (MUST)

call on 9909008213 or mail on jobs@techciel.com

Registration Department and R & D Registration Department and R & D 

Registration Department and R & D 

At the end of 2017, the MHRA published its latest GDP deficiency data and listed quality systems and transportation as the top categories for major deficiencies. Although medical authorities continue to push the advancement of supply chain quality and security, it is still a minefield to navigate.

We created the Pharma Logistics Compliance 2018 Report designed specifically to keep you up to date with key developments that we believe will shape the compliance agenda over the next year.

View the report>> http://bit.ly/2H0W0sK

Don’t miss out on special features including:
-Supply Chain Security and Traceability – GPS
-Brexit
-ICH Q12 Flexibility Initiatives
-EMA Regulations
-Emerging Markets and Regulations
-And more

View the report >> http://bit.ly/2H0W0sK

Interested in learning more about compliance? This topic will be covered in case studies and session at the 16th Annual Cold Chain Global Forum this September 24-27.

Find out more >> http://bit.ly/2xvZTqa

Join us and top pharma supply chain executives to address end-to-end supply chain optimization and create strategies to remain complaint with regulatory agencies, ensure quality compliance, and implement customer centricity to enhance patient first initiatives.

The international initiative AllTrials on Monday unveiled a new tracking tool to highlight clinical trial sponsors who fail to publish results as required by the FDA Amendments Act of 2007 (FDAAA).

In an open letter to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, urging the agency to crack down on such sponsors, AllTrials founders Ben Goldacre and Síle Lane explained how FDA has the power to “levy of fines up to $10,000 a day against clinical trial sponsors who fail to publish their trial results on ClinicalTrials.gov. There are, though, trials on that register whose results are years overdue, and to date you have not issued a single fine.”

The letter notes that relevant trials have 13 months from completion to post summary results and adverse event information, and that 17 February is 13 months since a final rule on FDAAA took effect.

AllTrials’ FDAAA noncompliance tracking tool also went live at FDAAA.TrialsTracker.net on Monday, using data from ClinicalTrials.gov to flag sponsors that are not compliant.

Read more: http://bit.ly/2EINoKI

AstraZeneca's immunotherapy Imfinzi (durvalumab) has secured approval from the US Food and Drug Administration (FDA) for unresectable stage III non-small cell lung cancer (NSCLC).
The approval is for the expanded use of Imfinzi to treat NSCLC patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).

Imfinzi, which is a human monoclonal antibody, functions by targeting the PD-1/PD-L1 pathway. The drug blocks the interaction of PD-L1 with PD-1 and CD80 proteins, thereby working against the immune-evading tactics of the tumor and releasing the inhibition of immune responses.

AstraZeneca executive vice president and oncology business unit head Dave Fredrickson said: “The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy.

Read more: http://bit.ly/2HuuNQs

Sorry Paul I never saw this post before - thank you for your very detailed reply.

For some reason I never got any notifications but I am sure that is just me.

Thanks again for your reply!

Luke, thank you for these comments. They are very much appreciated.
We are going to try to increase engagement in conversations by implementing a regular digest or newsletter over the next few weeks. At the moment, members only receive email alerts on conversations that are posted on topics they follow.
Most members probably don’t follow a topic, so I think maybe a weekly digest on PharmeMed updates may make a big difference without being overly intrusive. We will focus in other areas to increase traffic.
I also understand your concern about the platform being overly career focused. PharmeMed is not a job board, but we do allow free job posting. Jobs and career issues tend to be the most popular interest on most social networks and is a great to attract new members. At the moment, posted jobs are appearing in the home page feed. However, as soon as conversations kick off in a big way, we plan to remove jobs from the feed and display in the job database only.
Currently, a lot of the large social networking platforms appear to be appearing as clones of facebook rather than focusing on the qualities that made them great in the first place. I think there is definitely an opportunity for niche social networks across different sectors to focus on topics relevant to their sector – free of spam and free of posts best placed on facebook.
I appreciate your contributions to PharmeMed and your effort to make the site work better for everyone.
If everyone on PharmeMed currently recommended 9 members to join – we would have about 100,000 new members overnight!
PharmeMed may be a bit of a rough diamond at the moment, but once more and more valuable content is shared amongst members it will eventually shine bright.

This platform has something...

???? Something entirely new
???? Something entirely unique
???? Something that no one else exclusively has

They have: ???? YOU

I have been testing out LinkedIn, testing out Zing and testing out other platforms too to see who would be the most responsive.

Sadly Pharmemed isn't really competing in the grand scheme of things.

???? Pharmaceuticals is about networking and connectivity above all else, but I haven't heard from barely anybody about anything other than a few names spamming the feeds with job adverts.

???? This page isn't about just job hunting, it is about good content, good media, and good reputation. Currently, people aren't putting the effort in and it just doesn't help with the brand recognition that big names like LinkedIn are getting.

???? I have seen so many professionals that I am connected with on LinkedIn use this site but not one of them sharing the same content they do on LinkedIn!

WHEN IS IT GOING TO START?

Last Thursday (December 7), CRISPR Therapeutics submitted an application to European regulatory authorities seeking permission to begin clinical trials for CTX001, an investigational CRISPR treatment for patients with sickle cell disease and β thalassemia.

CRISPR Therapeutics, the company cofounded by Emmanuel Charpentier—one of the developers of CRISPR gene editing technology—plans to start a Europe-based Phase 1/2 trial for patients with β thalassemia in 2018. “I think it’s a momentous occasion for us, but also for the field in general,” Samarth Kulkarni, CEO of the company, tells Wired. “Just three years ago we were talking about CRISPR-based treatments as sci-fi fantasy, but here we are.”

The firm also plans to apply for US Food and Drug Administration approval to use the treatment for sickle cell disease early next year.

Patients with sickle cell disease and β thalassemia possess mutations in a gene that produces a subunit of hemoglobin, an oxygen-transporting protein in the blood. CTX001 works by cleaving BCL11A, a gene that represses the production of fetal hemoglobin, which is only produced early in life.

Read more: http://bit.ly/CRISPRClinicalTrials

Target Start Date: January 2nd, 2018
Contract: 6 months

Job Description:
Responsible for researching and executing regulatory tasks of moderate scope, complexity and risk. Performs regulatory due diligence of moderate complexity such as Class II products and requires the use of discretion and independent judgment when making decisions. Tasks may include proficiency at assignments such as establishment registration & listing, export certificate submissions, international product registrations, new product development support as well as the ownership of medium sized Regulatory Affairs projects.

Minimum Qualifications:
•3+ Yrs Exp
•BA/BS or Equiv Wrk Exp

Preferred Qualifications:
•Regulatory Affairs Certification (RAC)
•5+ Yrs Exp

Additional Job Descriptions:

The individual must have knowledge and understanding of ISO 13485:2003/2012 and ISO 13485:2016 requirements. Must understand the differences between the two revisions. Must be able to conduct a gap analysis to identify the gaps. Must be able to update/revise/create procedures based on ISO 13485:2016 requirements. Must be able to train departments to the new changes. Must be lead auditor certified by an accredited company. Must have an excellent communication skills and be able to work with different departments throughout the company.

AND/OR

The individual must have knowledge and understanding of US FDA, Canada, Australia, Brazil & Japan regulations. Must be able to implement these regulatory requirements into company’s Quality Management System through MDSAP. Must understand the grading system of MDSAP and be able to carry out the MDSAP audit for each site. Must be lead auditor certified by an accredited company. Must have an excellent communication skills and be able to work with different departments throughout the company.
Please email a copy of your resume to Jessica.Blume@DJOGlobal.com if you are interested in this position. Thank you.

http://www.djoglobal.com/

This still amazes me...

I put up a post a couple of weeks ago about a pharmaceutical startup and have had loads of responses, direct messages, emails etc. generally getting very excited about the role!

The post was a very short message about how I felt that pharmaceutical startups should get the same buzz as IT based companies and it seems that a lot of my network agree.

I wanted to thank everyone in my network for all their responses and I will be looking through each and everyone very carefully.

As a reminder, the role was for a Regulatory Affairs Specialist who has previous experience in APAC or MENA and has done DCP, MRP etc.

The main requirement of someone in this position is dealing with change of licence ownership - so if you have past experience of this it is a huge plus.

I am leaving applications open for a few more days so if you are interested please feel free to reach out to me on the details below:

✉ luke.blaney@rbwconsulting.com
☎ +44 (0) 1293 584 300
???? Get in touch now!

Please feel free to contact. There are lots of exciting projects coming up within the Pharmaceutical and Medical Device Industy across Europe.

We would be more than happy to hear from all specialists within this field!

Office Dial: +44 (0) 1442 869700
Direct Dial: +44 (0) 1442 860533
Email: Charles.holroyd@quanta-cs.com

Hi all,

Here at Quanta we currently have upcoming projects within the Regulatory Affairs field, working with some of the top Global Pharmaceutical companies. I was hoping to gauge who will be available from January 2018 for new project opportunities across the UK, Ireland, and Europe.  

Please contact either myself or my colleague with a copy of your CV so we can arrange a time to discuss your skills and the sort of project you would like to be involved in. 

Direct Dial: +44 1442 860 531

xanthe.glaysher@quanta-cs.com

Thanks!

Have a new vacancy for an officer that has just gone live.Once in a lifetime chance to get on the ladder with this fantastic global company based in East London.For the chance to apply email luke.blaney@rbwconsulting.com - I look forward to speaking to you soon.

I haven't received your CV as of yet. Can you please email it again to the email address and I will keep a look out for it.

Do you have any background experience in this area? - if you pop an email to luke.blaney@rbwconsulting.com I or one of my colleagues here can assist on this!