Glossary - Corporate Responsibility Report 2019

3R principle

The international guiding principle for all animal testing. The number of laboratory animals used as well as the stress placed on them before, during and after testing are to be kept to an absolute minimum by using methods to replace animal experiments (replacement), reduce the required number of tests and animals (reduction), and improve the test methods (refinement).

African sleeping sickness

Human African trypanosomiasis (HAT), also known as sleeping sickness, is a parasitic disease transmitted by the bite of the tsetse fly. The disease mostly affects poor populations living in remote rural areas of Africa. Untreated, it is usually fatal.

Big Data

Extremely large data sets that may be analyzed computationally to reveal patterns, trends and associations, especially relating to human behavior and interactions.

Biodiversity

The diversity of ecosystems, habitats and landscapes on earth, the diversity of the species, and the genetic diversity within a biological species or population.

Buruli ulcer

An infectious disease caused by bacteria that occurs most commonly in rural sub-Saharan Africa and Australia.

Chagas disease

A potentially life-threatening illness caused by the protozoan parasite. An estimated eight million people are infected worldwide, mostly in Latin America.

Chatbot

A computer program or an artificial intelligence that conducts a conversation via auditory or textual methods.

CLP

Short for “Classification, Labelling and Packaging of Substances and Mixtures”, this is a European regulation based on the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals.

CMP

Chemical Mechanical Planarization is a process of smoothing surfaces through chemical and mechanical forces.

Co-infection

Also known as a double infection, this involves the simultaneous infection of a host by multiple pathogen species that can negatively influence the disease process and lead to higher mortality.

CO₂ equivalents

CO₂ equivalents (CO₂eq) indicate how much a specified quantity of a specific greenhouse gas contributed to the greenhouse effect, using the global warming potential of carbon dioxide as a reference.

Compliance

Adherence to laws and regulations as well as to voluntary codices that are internal to a company. Compliance is a component of diligent corporate governance.

CRISPR/Cas

A biomolecular method for targeting, cutting and editing the DNA of an organism (gene editing). Experts think this technique has great potential for curing diseases or generating plants and animals with new traits.

Design thinking

An approach to developing new ideas. Design thinking uses the designer’s sensibility and methods to match people’s needs with what is technologically feasible and what a viable business strategy can convert into customer value and market opportunity.

DMF

Dimethylformamide is a clear, colorless, hygroscopic liquid with a high dielectric constant. It is employed as a solvent in the production of textiles, pharmaceuticals, pesticides, and adhesives. The ECHA (European Chemicals Agency) has designated DMF as a substance of very high concern (SVHC) and included it in the candidate list for authorization.

Dual-use products

Goods that are normally used for civilian purposes, but that may also have military applications.

Due diligence

A risk analysis exercised with particular care.

EHS

Short for “Environment, Health and Safety”, this refers to environmental management, health protection and occupational safety throughout a company.

End-user declaration

A binding customer statement regarding the intended use of a product.

Endemic countries

Countries in which a certain disease, in many cases an infectious disease, occurs.

EQ

Our Group Environment, Health, Safety, Security, Quality function.

Equality Act

A pending U.S. law with a special focus on LGBTQ people (lesbian, gay, bisexual, transgender, queer). It prohibits discrimination on the basis of the sex, sexual orientation and gender identity.

ESG ratings

These are used to assess a company’s financial performance through factors that include aspects of environmental management, social issues and good governance.

Essential medicines

Defined by the World Health Organization as “those drugs that satisfy the health care needs of the majority of the population”.

Exposure assessment

The U.S. Environmental Protection Agency defines exposure assessment as the determination or estimation (qualitative or quantitative) of the magnitude, frequency, duration, and route of exposure between an agent and an organism. This analysis forms part of the chemical safety assessment process.

FDA

The U.S. Food and Drug Administration is the U.S. government agency responsible for protecting and advancing public health, especially as concerns food and drugs.

First-line treatment

A therapy regimen that is generally accepted by the medical establishment for the initial treatment of a given disease. If the first-line treatment is not adequately successful, a second-line treatment may be administered.

Freshwater

Water containing 1,000 mg or less of dissolved solids per liter.

Global Product Strategy

An initiative of the International Council of Chemical Associations (ICCA) through which participating companies of the chemical industry make a commitment to comprehensive product responsibility.

Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

An international standard system to classify chemicals that covers labeling as well as safety data sheets.

Good clinical practice (GCP)

An international quality standard that enforces tight guidelines on ethical aspects of clinical studies.

Good distribution practice (GDP)

An EU guideline that regulates the proper distribution of medicinal products for human use.

Good manufacturing practice (GMP)

A system for ensuring that products are consistently manufactured and controlled according to quality standards. These guidelines are used in the production of medicines, active pharmaceutical ingredients and cosmetics, as well as foodstuffs and feed.

Greenhouse gases

Gases in the atmosphere that contribute to global warming. They can be either naturally occurring or caused by humans (such as CO₂ emissions generated by burning fossil fuels).

GxP

The general term for good practice quality guidelines and regulations that are used in many fields, especially the medical, pharmaceutical and pharmaceutical chemistry industries.

HazCom 2012

A U.S. OSHA (Occupational Safety and Health Administration) standard pertaining to the safe handling of chemicals in the workplace, with an emphasis on occupational safety and environmental protection. This standard requires manufacturers and distributors to provide information on the hazards posed by a product as well as ways to minimize risks.

Humanoid

A term that means human-like.

ICH

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) aims to promote uniform assessment criteria for product registration in Europe, the United States and Japan. The ICH develops guidelines for the evaluation of the quality, effectiveness and safety of medicinal products.

In vitro

Procedures involving components of an organism that were isolated from their usual biological surroundings (such as test tube experiments).

In vivo

Latin for “within the living”, this term describes processes that take place within a living organism.

Investigational drug

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including approved as well as unapproved products when used or assembled (formulated or packaged) in a way different from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.

ISO 14001

This international environmental management standard sets globally recognized requirements for an environmental management system.

ISO 50001

This international standard defines globally recognized requirements for energy management systems.

ISO 9001

This international standard defines globally recognized requirements for a quality management system.

Lead substances

Manufacturers/importers of a certain substance must submit a joint registration according to REACH. In this context, the company responsible for collecting the substance data and preparing the registration dossier uses the term “lead substance”.

Leishmaniasis

A group of diseases caused by protozoan parasites. These parasites are transmitted to humans by the bites of the infected female phlebotomine sand fly. There are three main forms of leishmaniasis: cutaneous, visceral or kala-azar, and mucocutaneous.

LGBT+, LGBTQ, LGBTQI

These acronyms stand for lesbian, gay, bisexual, transgender, queer or questioning, and intersex.

Liquid biopsy

Sampling and analysis of non-solid biological tissue such as blood.

Liquid crystals (LC)

A hybrid of a crystalline and liquid state. In general, molecules are perfectly arranged only when in a solid crystal state, in contrast to the liquid state, when they move around chaotically. However, liquid crystals are a hybrid of the two states: Although they are liquid, they exhibit a certain crystalline arrangement. Their rod-shaped molecules align themselves like a shoal of fish. In addition, they respond to the electromagnetic waves of light like tiny antennae. Therefore, such swarms of molecules can either allow specially prepared “polarized” light to pass through, or they can block it. This takes place in the pixels of liquid crystal displays – as it does similarly in liquid crystal windows, which can provide shade against sunlight.

Liver-stage malaria

Certain forms of the malaria parasite (P. vivax and P. ovale) can remain dormant after infecting liver cells. In this stage, they persist for many weeks and even years until they relapse into a new disease cycle. Currently, it is not possible to treat this dormant form.

Location-based approach

The location-based method quantifies the Scope 2 emissions that are emitted on average in the area where the electricity consumption takes place. As a rule, the average at country level is used.

LTIR

The lost time injury rate measures the number of accidents resulting in missed days of work (one or more days) per one million man-hours.

Managing director

At our company this individual is ultimately responsible for ensuring that their subsidiary, including R&D and manufacturing centers, complies with all laws and regulations applicable to its business, including guidelines.

Market-based approach

This method quantifies the GHG emissions emitted by an electricity supplier or an individual electricity product.

Memorandum of understanding (MoU)

A type of agreement between two or more parties. It expresses a convergence of will between the parties, indicating an intended common line of action.

Monoclonal antibodies

Monoclonal antibodies are proteins that specifically recognize and bind to other unique proteins called antigens.

Neglected tropical disease (NTD)

Diseases that occur primarily in developing countries. NTDs include schistosomiasis, intestinal worms, trachoma, lymphatic filariasis, and onchocerciasis. This group of diseases is called neglected because, despite the large number of people affected, they have historically received less attention and research funding than other diseases.

NMP

N-Methyl-2-Pyrrolidone a polar aprotic compound that is miscible with water and has good solvency properties. NMP is used in the manufacture of polymers, semiconductors, batteries and pharmaceuticals. The ECHA (European Chemicals Agency) has designated NMP as a substance of very high concern (SVHC) and included it in the candidate list for authorization.

Nucleases

A group of enzymes whose primary function is to partially or fully degrade nucleic acids.

OHSAS

The Occupational Health and Safety Assessment Series (OSHAS) is an international occupational health and safety management system.

Onchocerciasis

A chronic parasitic infection caused by nematodes that occurs in the tropical regions of Africa and South America. In approximately 10% of those infected, the disease leads to blindness, which is why onchocerciasis is also referred to as river blindness.

Organoid

An organoid is a miniaturized and simplified version of an organ produced in vitro in three dimensions by means of a cell culture. It shows realistic micro-anatomy similar to an organ. Organoids are derived from one or a few tissue cells, embryonic stem cells or induced pluripotent stem cells, which can self-organize in a three-dimensional culture, owing to their self-renewal and differentiation capacities. Organoids are, among others, used as model systems in the investigation of diseases and the development of drugs.

Orodispersible tablet

A tablet that dissolves in the mouth within 30 seconds and does not have to be taken with water. The active ingredient is absorbed through the mucous membrane in the mouth and also partly through the lining of the stomach.

Other water

Water containing more than 1,000 mg of dissolved solids per liter.

Patent pool

A consortium of at least two competing companies that allows partners to share the use of patents relating to a particular technology.

Patient access programs

Self-sustaining commercial programs with a revenue-driven purpose which provide medicines for underserved populations, either through free products or a reduced treatment fee.

Patient support programs

Any organized system providing services and direct patient or patient-caregiver interactions that are intended and designed to educate patients about certain diseases, and help patients with access to and/or the management of prescribed medicines and/or disease outcomes and/or offer doctors support for their patients.

Pharmacovigilance

The science and activities related to the detection, evaluation, understanding, and prevention of adverse reactions or other drug-related problems.

Phase I study

Phase I clinical trials test a new biomedical intervention in a small group of people (for example, 20-80) for the first time to evaluate safety (for instance, to determine a safe dosage range and to identify side effects).
Source: http://www.who.int/ictrp/glossary/en/

Phase II study

Phase II clinical trials study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety.
Source: http://www.who.int/ictrp/glossary/en/

Phase III study

Phase III studies investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.
Source: http://www.who.int/ictrp/glossary/en/

Prediabetes

A condition regarded as indicative that a person is at risk of progressing to Type 2 diabetes.

Process-related emissions

Greenhouse gases released into the atmosphere during manufacturing operations.

Product safety summary

Intended to provide a general overview of the chemical substance and its use. It cannot take the place of a safety data sheet.

Public-private partnership (PPP)

A collaboration between public sector (government) organizations, private companies and/or not-for-profit organizations.

REACH

A European Union chemical regulation (EC No. 1907/2006) that took effect on June 1, 2007. REACH stands for Registration, Evaluation, Authorization, and Restriction of Chemicals.

Registration dossiers

One part of the complex and time-consuming REACH registration process is the preparation of a technical dossier and its submission to the European Chemicals Agency (ECHA). The information that a registration dossier should contain includes the physical-chemical, toxicological and ecotoxicological characteristics of the substances, human and environmental exposure, intended uses, classification and labelling, and recommended risk management measures.

Risk-sharing agreement

An agreement between the producer or manufacturer and the payer or provider that allows access to a health technology through coverage or reimbursement under certain conditions.

Role

Merck KGaA, Darmstadt, Germany uses a market-oriented system to rate positions within the company. To facilitate consistency across the organization, each position is assigned a specific role, with an overarching job architecture classifying each role as one of 11 levels, 15 functions and an array of career types (Core Operations, Services & Support Groups; Experts; Managers; Project Managers).

Schistosomiasis

A parasitic disease spread in warm lakes and ponds by snails that serve as intermediate hosts.

Scope 3

Scope 3 includes indirect greenhouse gas emissions, such as the extraction and production of purchased materials, transport-related activities, waste disposal, and employee travel.

Scorecard

An evaluation tool for measuring, documenting and controlling activities using metrics.

Scrum

A framework for agile project management. It is a method that is simple, flexible and quick to deliver results.

Security

This term stands for all necessary measures and governance activities to detect, analyze, handle, and mitigate security- and crime-based threats to the company. This helps to protect employees as well as the tangible and intangible assets of the company.

Signal management

A set of activities performed to determine whether, based on an examination of individual case safety reports, aggregated data from active surveillance systems or studies, scientific literature information, or other data sources, there are new risks associated with an active substance or a medicinal product or whether known risks have changed, as well as any related recommendations, decisions, communications, and tracking.

Spontaneous reports on adverse effects

If a side effect occurs while using a medicine and is reported, this is called a spontaneous report because the adverse reaction is reported spontaneously (for example by doctors or patients) and not in a trial or an observational study.

Stakeholder

People or organizations that have a legitimate interest in a company, entitling them to make justified demands. Stakeholders include people such as employees, business partners, neighbors in the vicinity of our sites, and shareholders.

STEM

Science, technology, engineering, and mathematics.

Stem cell lines

Groups of stem cells derived from animal or human tissue. They can be cultivated in vitro and multiply indefinitely.

Stem cells

Undifferentiated cells with the potential to develop into many different cell types that carry out different functions.

Sunshine Act

The Sunshine Provisions of the U.S. Patient Protection and Affordable Care Act aim to create more transparent relationships between manufacturers of drugs, medical devices and medical aids on the one hand, and doctors and teaching hospitals on the other.

Traces

Substances dissolved in water that are present only in minute amounts. Also referred to as micropollutants, these are synthetic substances present in concentrations ranging from one nanogram to one microgram per liter of water.

Transfer of value

Direct and indirect transfers of value, whether in cash, in kind or otherwise (for instance promotional purposes).

TRIPS

The Agreement on Trade-Related Aspects of Intellectual Property Rights is an international legal agreement between all the member nations of the World Trade Organization. TRIPS seeks to ensure that the measures and procedures for enforcing intellectual property rights do not become a barrier to lawful trade.

WASH

This stands for “water, sanitation and hygiene”.

WLTP

Lawmakers require standardized test procedures to measure how much fuel a car consumes and whether it complies with the emissions limits. The new Worldwide Harmonised Light Vehicle Test Procedure (WLTP) took effect in the EU on September 1, 2017 and is now the official type approval testing procedure for new passenger cars across the EU. It succeeded the NEDC (New European Driving Cycle), which took effect in 1992.

Working out loud

This technique is about deliberately sharing and providing knowledge as well as forming relevant working relationships. The goal is to discover new topics and ideas.

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