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Regulatory Harmonisation

June 14, 2017

Schlafender Hase Team

In Perfect Harmony? What will Brexit Mean for Regulatory Harmonisation

The global market is currently experiencing a turbulent period, as national elections continue, governments change and the UK edges closer to Brexit. One of the practical concerns for life sciences is how this might affect the regulatory landscape, and momentum behind specific regulatory developments such as the phasing in of ISO Identification of Medicinal Products (IDMP).

Regulatory Harmonisation
  • June 14, 2017
  • By: Dr. Jutta Hohenhoerst
4 minutes read

In Perfect Harmony? What will Brexit Mean for Regulatory Harmonisation

The global market is currently experiencing a turbulent period, as national elections continue, governments change and the UK edges closer to Brexit. One of the practical concerns for life sciences is how this might affect the regulatory landscape, and momentum behind specific regulatory developments such as the phasing in of ISO Identification of Medicinal Products (IDMP).

IDMP Solutions

June 5, 2017

Schlafender Hase Team

Behind the Smoke & Mirrors of IDMP Solutions

Life sciences technology vendors and consultancies are busy promoting Identification of Medicinal Products (IDMP) compliance solutions, which seems odd given that many details of the final requirements have yet to be published. With a further two years to go until the latest deadline comes around, organisations have every reason to be sceptical of the value of investing now, says Marc Chaillou of Schlafender Hase.

IDMP Solutions
  • June 5, 2017
  • By: Marc Chaillou
6 minutes read

Behind the Smoke & Mirrors of IDMP Solutions

Life sciences technology vendors and consultancies are busy promoting Identification of Medicinal Products (IDMP) compliance solutions, which seems odd given that many details of the final requirements have yet to be published. With a further two years to go until the latest deadline comes around, organisations have every reason to be sceptical of the value of investing now, says Marc Chaillou of Schlafender Hase.

Data Harmonisation

April 27, 2017

Schlafender Hase Team

Data Harmonisation in a Fragmenting Market: Brexit & IDMP

Harnessing automation is one way to minimise the burden on skilled personnel. When it comes to organising and verifying definitive source documents, checking for accuracy and currency, and comparing these across different languages, file and font types, there are now sophisticated tools that can help relieve the pressure on already time-starved teams – taking care of the heavy lifting so the overseeing professionals only need to proof content once, as a final check.

Data Harmonisation
  • April 27, 2017
  • By: Dr. Jutta Hohenhoerst
3 minutes read

Data Harmonisation in a Fragmenting Market: Brexit & IDMP

Harnessing automation is one way to minimise the burden on skilled personnel. When it comes to organising and verifying definitive source documents, checking for accuracy and currency, and comparing these across different languages, file and font types, there are now sophisticated tools that can help relieve the pressure on already time-starved teams – taking care of the heavy lifting so the overseeing professionals only need to proof content once, as a final check.

Cross-border compliance efforts

April 10, 2017

Schlafender Hase Team

Life Sciences’ Shifting Sands: 5 Trends that Threaten the Status Quo

Change is the only constant in the new normal, something that applies as much to life sciences now as to other markets more readily associated with disruption, such as retail and banking. But the pharmaceutical industry is not known for its adaptability, so how will it weather the choppy conditions currently characterising the market - and can technology ease the strain?

Cross-border compliance efforts
  • April 10, 2017
  • By: Marc Chaillou
5 minutes read

Life Sciences’ Shifting Sands: 5 Trends that Threaten the Status Quo

Change is the only constant in the new normal, something that applies as much to life sciences now as to other markets more readily associated with disruption, such as retail and banking. But the pharmaceutical industry is not known for its adaptability, so how will it weather the choppy conditions currently characterising the market - and can technology ease the strain?

Correction Cycles

February 13, 2017

Schlafender Hase Team

Counting the Cost of Corrections in Clinical Trials Labeling

Within all of this, the clinical trials process carries its own particular share of risks and associated costs. If drugs do not pass human testing – and most don’t – all of the work that precedes this will have been for nothing: certainly it will not deliver the expected return. So life sciences companies need robust processes in place to ensure that products are taken absolutely correctly, leaving no scope for error in dosage, for example.

Correction Cycles
  • February 13, 2017
  • By: Peter Muller
7 minutes read

Counting the Cost of Corrections in Clinical Trials Labeling

Within all of this, the clinical trials process carries its own particular share of risks and associated costs. If drugs do not pass human testing – and most don’t – all of the work that precedes this will have been for nothing: certainly it will not deliver the expected return. So life sciences companies need robust processes in place to ensure that products are taken absolutely correctly, leaving no scope for error in dosage, for example.

Regulators Hunger for Control of Nutrition and Nutraceuticals

September 1, 2016

Schlafender Hase Team

Regulators Hunger for Control of Nutrition and Nutraceuticals

The life sciences industry, keen to reduce its reliance on expensive blockbuster drugs, has recognised the opportunity and wants its share of the action. Many firms are now embracing health foods and nutraceuticals through acquisition or partnership, or the expansion of existing businesses to include new divisions.

Regulators Hunger for Control of Nutrition and Nutraceuticals
  • September 1, 2016
  • By: Peter Muller
6 minutes read

Regulators Hunger for Control of Nutrition and Nutraceuticals

The life sciences industry, keen to reduce its reliance on expensive blockbuster drugs, has recognised the opportunity and wants its share of the action. Many firms are now embracing health foods and nutraceuticals through acquisition or partnership, or the expansion of existing businesses to include new divisions.

prominent trends in life sciences

August 30, 2016

Schlafender Hase Team

The Long Arm of the Regulator

It is no coincidence that the food and nutraceuticals industries are now beginning to look to these more experienced sectors – particularly pharma - for guidance on best practices – and as a source of regulatory professionals as they seek to bolster their teams.

prominent trends in life sciences
  • August 30, 2016
  • By: Peter Muller
7 minutes read

The Long Arm of the Regulator

It is no coincidence that the food and nutraceuticals industries are now beginning to look to these more experienced sectors – particularly pharma - for guidance on best practices – and as a source of regulatory professionals as they seek to bolster their teams.

Food and Pharma Regulators

August 1, 2016

Schlafender Hase Team

Food and Pharma: The Broadening Reach of Regulators

Its new Nutrition Facts label guidance, which applies to packaged foods, will ensure that labelling reflects the latest scientific information, including the link between diet and chronic diseases, for example. New requirements also include updated serving sizes, and a refreshed design which highlights information such as calorie content, portion size, added sugar content. New nutrients must be declared too, including Vitamin D and potassium, to combat associated deficiencies.

Food and Pharma Regulators
  • August 1, 2016
  • By: Peter Muller
5 minutes read

Food and Pharma: The Broadening Reach of Regulators

Its new Nutrition Facts label guidance, which applies to packaged foods, will ensure that labelling reflects the latest scientific information, including the link between diet and chronic diseases, for example. New requirements also include updated serving sizes, and a refreshed design which highlights information such as calorie content, portion size, added sugar content. New nutrients must be declared too, including Vitamin D and potassium, to combat associated deficiencies.

Food Follows Pharma into Tighter Regulatory Territory

July 27, 2016

Schlafender Hase Team

Food Follows Pharma into Tighter Regulatory Territory

In the fast-growing nutraceuticals market, rules are becoming stricter too. Authorities in Scandinavia are clear that if nutrition companies are going to start making medicinal claims about their products, they must categorise themselves as pharmaceutical businesses and be bound by similar requirements. And countries from Japan and India to Canada have already put the regulatory wheels in motion.

Food Follows Pharma into Tighter Regulatory Territory
  • July 27, 2016
  • By: Peter Muller
3 minutes read

Food Follows Pharma into Tighter Regulatory Territory

In the fast-growing nutraceuticals market, rules are becoming stricter too. Authorities in Scandinavia are clear that if nutrition companies are going to start making medicinal claims about their products, they must categorise themselves as pharmaceutical businesses and be bound by similar requirements. And countries from Japan and India to Canada have already put the regulatory wheels in motion.

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