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2 days ago | 
hedleyrees.substack.com | Hedley Rees
Given my specialist subject, Supply Chain Management in the Drug Industry, I’m thinking that subscribers may want me to focus on what I know after 40 years in the pharmaceutical industry. Then, I was a thought leader and modernizer who was highly regarded.
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5 days ago | 
hedleyrees.substack.com | Hedley Rees
Goliath was a giant, covered from head to toe in armour, armed to the teeth. David was diddy (little, for our non-UK friends). He was a lowly shepherd, without a scrap of armour, and only a sling and stone to defend himself with. How on earth did David slay Goliath? Such an apparent total mis-match……or so it seemed—but looks can be deceiving.
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1 week ago | 
hedleyrees.substack.com | Hedley Rees
The lifecycle of a development programme for a medicinal product begins with pre-clinical assessment of a batch (lot), or batches of the active pharmaceutical ingredient (API) at small (pilot) scale. Batches are pre-GMP (GMP = Good Manufacturing Practice).
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1 week ago | 
hedleyrees.substack.com | Hedley Rees
You may not know, but the UK Government has been making up to big pharma for nearly 25 years now. It began with the formation of the Ministerial Industry Strategy Group in 2001.
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2 weeks ago | 
hedleyrees.substack.com | Hedley Rees
[Note: This is from June, 2024]Office of the Executive SecretariatUS Food & Drug Administration5630 Fishers Lane, Room 1050Rockville, MD 20857FDA FOIA reference file:2024-5142Dear Office of the Executive Secretariat,I am in contact with Ms. Sly in relation to the FOIA reference above.
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2 weeks ago | 
hedleyrees.substack.com | Hedley Rees
[Note: This is from 2022]In a previous update, I commented on how MHRA has relied upon remote inspections of companies developing and manufacturing the mRNA injections, as well as those carrying out clinical trials. This MHRA Blog, titled Global reflections on international inspection transformation: ICMRA remote inspections, introduces the concept on behalf of the International Coalition of Medicines Regulatory Authorities (ICMRA).
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2 weeks ago | 
hedleyrees.substack.com | Hedley Rees
I’m starting this post by reinforcing the importance of every subscriber to this newsletter. Free or paid, the information posted will not be found anywhere else, given the poorly understood role of supply chain integrity in keeping patients safe. In the last 30-days, according to Substack’ s statistics, there have been 86,262 post views, with an open rate of just over 25%. The total number of subscribers is currently 7,468, with 120 paying subscribers.
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2 weeks ago | 
hedleyrees.substack.com | Hedley Rees
[Please note: this is the first post from INSIDE PHARMA, dated January 13th 2021. Some of the links may not now work, due to the passage of time]Industry-leading biopharmaceutical supply-chain management consultancy PharmaFlow has today repositioned itself in the market with the launch of a brand-new website and business proposition.
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2 weeks ago | 
hedleyrees.substack.com | Hedley Rees
[Note: This is recycled from June 2024] Open letter to interim co-chair at UKs MHRA: Should the need for a product recall of the AstraZeneca sterile injectables be investigated by the Defective Medicines Report Centre? Well, the open letter was passed on to Professor Cooke on Tuesday, June 18. I asked for his urgent attention.
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2 weeks ago | 
hedleyrees.substack.com | Hedley Rees
That goes back over 10 years and had 13 million views. I always found John Oliver incredibly funny myself, so apologies if he is not to your taste. For me, the clip, where the aggressive pharma representative tears a strip off the doctor for not writing enough ‘scripts, says it all!Why did people go along with the Big Pharma narrative during COVID???
